| | NICAS Ref | Published Ref | Title | Summary | Broadcast Date |
| Select | NICAS-1052 | DSI-2024-005 | Symbios ORIGIN Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision | ORIGIN is a patient matched total knee replacement prosthesis available in postero-stabilized (PS) and cruciate retaining (CR) versions.
Affected catalogue and lot numbers: Refer to the Field Safety Notice (FSN) issued by the manufacturer for details on the affected devices.
The National Joint Registry (NJR) has identified that the ORIGIN® device family has a significantly higher revision rate compared with all other bicondylar knees. Similarly, performance of the ORIGIN® device family in the UK is significantly worse than all other comparable regions, European and Worldwide, where this device is commercialised. | 23/04/2024 |
| Select | NICAS-1051 | DSI-2024-004 | 0.9% Sodium Chloride Solutions for Irrigation, Legency Remedies - Recall | Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination. Specific Batch Numbers detailed in the FSN. | 05/04/2024 |
| Select | NICAS-1049 | DSI-2024-003 | Counterfeits and unbranded copies of LifeVac anti-choking devices | Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed.
There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which have not been validly UKCA or CE marked and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.
| 25/03/2024 |
| Select | NICAS-1050 | DSI-2024-002 | MAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted | The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK. | 12/03/2024 |
| Select | NICAS-1048 | DSI-2024-001 | Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease: UPDATE | The MHRA has updated our previous guidance (DSI-2022-003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD). Following an extensive review of the most recent published literature and consultation with the Interim Devices Working Group (IDWG) and invited experts, the MHRA recommends that PCD may be considered as a viable treatment option in both critical limb ischaemia (CLI) and intermittent claudication (IC) patients.
Previous advice relating to using the lowest dose devices available and avoiding/reducing repeated exposure of paclitaxel coated devices is also withdrawn. Adverse incidents should be reported nationally, and follow-up data should be captured via the National Vascular Registry.
| 05/02/2024 |
| Select | NICAS-1047 | DSI-2023-011 | Carbomer Eye Gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel | There is a potential risk of contamination of the gel with a type of bacteria called Burkholderia cenocepacia. An investigation by UKHSA has found an association with these eye gels, which are medical devices. Investigation and testing is still ongoing and these eye gels are being recalled as a precaution. | 24/11/2023 |
| Select | NICAS-1046 | EFN2302 | Oxygen Regulator fitted to Medical Air Cylinder | A bullnose regulator marked for oxygen administration was attached to a medical air cylinder in
error and placed on a transfer trolley. The cylinder colour coding and label indicated medical air. A
portable ventilator was connected to the oxygen regulator on the medical air cylinder in
preparation for a patient requiring oxygen while being transferred. | 23/11/2023 |
| Select | NICAS-1045 | DSI-2023-010 | SteriFeed Colostrum Collection device and risk of choking | When used as an infant feeding device with the cap still attached to the syringe, the cap can easily get dislodged and become stuck in the baby’s throat. Ensure the cap is removed from the tip of the syringe before using the device. | 10/10/2023 |
| Select | NICAS-1044 | DSI-2023-009 | No-React - cardiovascular bioprosthesis implantables: CE Withdrawal | No-React® cardiovascular bioprosthesis implantables: remaining stock may continue to be used. The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing. | 04/09/2023 |
| Select | NICAS-1043 | NatPSA/2023/010/MHRA | Medical beds, bed rails and bed grab handles: risk of death from entrapment or falls. | The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails (also known as bed safety rails), trolleys, bariatric beds, lateral turning devices and bed grab handles (also known as bed levers or bed sticks). According to investigations, deaths were found to involve factors including inadequate risk assessment, maintenance issues and children and adults of small stature using beds which are designed for use by adults with typical body dimensions. | 31/08/2023 |
| Select | NICAS-1041 | DSI-2023-008 | Aurum pre-filled syringes incompatibility with some manufactured needle-free connectors: | Attaching an incompatible needle free connector (NFC) to an Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-filled syringes from the Aurum range. | 22/08/2023 |
| Select | NICAS-1042 | DSI-2023-007 | EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs): resupply of specific batches | The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses. | 03/08/2023 |
| Select | NICAS-1040 | NISN-2023-01 | Risk assoicated with RAAC Planks | The Standing Committee on Structural Safety (SCOSS) issued an alert – “Failure of Reinforced Autoclaved Aerated Concrete (RAAC) Planks” in May 2019 . They advised that RAAC planks are much weaker than traditional concrete planks and are prone to degradation over time, resulting in a useful life estimated to be around 30 years. | 03/07/2023 |
| Select | NICAS-1039 | NatPSA/2023/005/MHRA | Removal of Philips Health Systems V60 and V60 Plus ventilators from service | This alert concerns all Philips Respironics V60 and V60 Plus non-invasive ventilators. The MHRA is issuing updated advice that these ventilators must be permanently removed from use.
PLEASE NOTE: this is a different alert to the one published on 29/03/2022 by the MHRA for thisrange of devices.
This alert should be acted on immediately.
This alert is for action by: All hospital trusts and other healthcare providers using the affected ventilators.
This advice is issued following a thorough scientific review of the updated evidence, and recent regulatory issues in consultation with a number of external stakeholders and the MHRA’s independent Interim Devices Working Group. It has been concluded that the benefits of these devices no longer outweigh the potential risks.
| 18/05/2023 |
| Select | NICAS-1037 | DSI/2023/006 | NuVasive Specialised Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted | Device Details
PRECICE Titanium Systems – Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom. Affected lot numbers/serial numbers: Refer to FSN for affected devices. Manufactured by NuVasive Specialized Orthopedics (NSO)
Summary
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom) can now be used in adults in the UK.
NSO has agreed to meet a set of conditions to effectively monitor the long-term biological safety of the devices.
The CE marks for PRECICE Biodur systems (Bone Transport, Stryde and Plate) have not been reinstated and these devices remain suspended from the UK market. | 12/04/2023 |
| Select | NICAS-1038 | DSI/2023/005 | Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion UPDATE | The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).
Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid (update to DSI/2023/002), DSI/2023/005 | 04/04/2023 |
| Select | NICAS-1036 | DSI-2023-004 | BD BodyGuard MicroSets and residual ethylene oxide | BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above. | 20/02/2023 |
| Select | NICAS-1035 | DSI/2023/003 | NexGen Knee replacement: affected patients should be offered additional follow up | The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral, had a higher overall revision rate and a higher revision rate for aseptic tibial loosening compared to the average revision rate of all other total knee replacements in the UK NJR (table 1). Additional follow up should be offered to all patients implanted with these specific combinations of components. | 15/02/2023 |
| Select | NICAS-1033 | NatPSA/2023/003/MHRA | NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): increased intraocular pressure | The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distributed by Bausch + Lomb U.K. Ltd.
Please return any comments by 10am on Monday 30th January | 01/02/2023 |
| Select | NICAS-1034 | DSI/2023/002 | Belzer UW Cold Storage Solution & Belzer MPS UW Machine Perfusion Solution -Contamination of fluid | Carnamedica, the manufacturer of these products, has identified issues with third-party suppliers, which could result in:
Microbiological contamination,
Particulate matter within the solution, and
Leakage of fluid.
Belzer UW Cold Storage Solution (CSS) is intended for flushing and cold storage of kidney, liver and pancreas organs at the time of their removal from the organ donor in preparation for storage, transportation and eventual transplantation into a donor recipient.
Belzer UW Machine Perfusion Solution (MPS) is intended for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. | 31/01/2023 |
| Select | NICAS-1032 | DSI/2023/001 | EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs) | MHRA Device Safety Information - EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses
The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).
| 26/01/2023 |
| Select | NICAS-1029 | EFN2301 | Assistance call alarm for accessible toilet: inappropriate use of isolation switch | A user who fell and sustained an injury in an accessible toilet was unable to activate the assistance call alarm as it had been inappropriately isolated. Recommendations are given on the installation, use and management of local assistance call alarms. | 23/01/2023 |
| Select | NICAS-1031 | NatPSA/2022/009/MHRA | Anyone with Prenoxad (naloxone) injection kits must check for missing needles | This has alert has also been issued via the usual channels as a Medicine Alert.
Prenoxad 1mg/Ml Solution For Injection In A Pre-Filled Syringe, Macarthys Laboratories, (Aurum Pharmaceuticals Ltd),
Caution Due To Potential Needles In Sealed Kits | 11/11/2022 |
| Select | NICAS-1028 | DSI-2022-004 | Haemodialysis and haemofiltration machines: Actions to avoid unintentional alteration of alarm limit | Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. If the cause of the alarm is not addressed, the machine may not re-alarm to alert the user to an ongoing problem. | 21/09/2022 |
| Select | NICAS-1027 | NatPSA/2022/004/MHRA | NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis | The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA). | 26/05/2022 |
| Select | NICAS-1026 | DSI-2022-003 | Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Updated position | In 2021 the MHRA reconvened the independent Expert Advisory Group (EAG) to review new evidence.
Following the review, the MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia has been updated to take into account potential dose dependent effects of paclitaxel coated balloons and stents in patients. | 06/04/2022 |
| Select | NICAS-1025 | NatPSA/2022/002/MHRA | Philips Respironics V60, V60 Plus and V680 ventilators – potential unexpected shutdown | Philips Respironics V60, V60 Plus and V680 ventilators – potential unexpected shutdown leading to complete loss of ventilation
In March 2022 Philips Health Systems informed the MHRA of an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings are also affected.
If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. This can include hypoxia, which can result in long-term cognitive impairment to the patient. There is also a risk of death if a patient is without ventilation for a sustained period of time.
Philips has no permanent solution to correct this issue and as such we are issuing this alert to help hospitals manage the risk. | 29/03/2022 |
| Select | NICAS-1022 | NISN-2022-001 | Reporting of Medical Device and Estates Adverse Incidents | Reporting of Medical Device and Estates Adverse Incidents and Disseminating Alerts | 22/02/2022 |
| Select | NICAS-1023 | DSI-2022-001 | Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths Gemini Surgical | Actions for the Patient Safety Lead in Healthcare Institutions. To be completed by 28 February 2022
Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK – All Lots and batches.
The MHRA is aware of devices being distributed by Gemini Surgical UK that do not have a valid safety certificate known as a CE mark or UKCA mark. This means that the safety of these devices cannot be confirmed, and you should stop using them. They may also be labelled as Gemini Medical Innovations.
The affected devices are:
1. Insulated Medium Cusco Speculum with smoke tube REF GEM/6171
2. Gynaecological set hysteroscopic sheath REF SPHS1870
Due to the unknown potential risks to patient safety, MHRA wants to ensure that necessary steps are taken to safeguard public health by ceasing the use of these devices in the UK. It is important that you inform all relevant departments and ensure that the required actions are carried out.
| 17/02/2022 |
| Select | NICAS-1021 | DSI-2022-002 | Surdial X Haemodialysis machine: potential to remove excess fluid outside of machine specification | The Surdial X haemodialysis machine is manufactured by Nipro Medical.
All serial numbers of this model are affected by this safety issue.
Haemodialysis is a treatment given to patients whose kidneys do not function fully or at all. The machines and associated items such as filter and tubing lines perform the function of the human kidney, to clean and filter the blood and remove fluid.
The MHRA are aware of the Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
| 17/02/2022 |
| Select | NICAS-1018 | SHOT/2022/001 | Preventing transfusion delays in bleeding and critically anaemic patients | Transfusion delays are preventable. Patients should not die or suffer harm from avoidable delays in transfusion.
The urgent provision of blood components and/or blood products is vital for life threatening bleeding and severe anaemia as in the body of the alert.
A rapid, focused approach is required as delays can result in preventable death or end-organ damage. | 17/01/2022 |
| Select | NICAS-1020 | DSI-2021-010 | Rheovalves Needle Free Connector - Baihe Medical | Baihe Medical have identified an increase in complaints for Rheovalves Disposable Needle-Free valve products. The manufacturer had previously issued a Field Safety Notice, however this information has now been superseded. Baihe Medical have requested that use of the device is now stopped with immediate effect whilst their investigation is underway. | 20/12/2021 |
| Select | NICAS-1016 | EFN-2021-01 | DiversiTech PAC12 & PAH12 portable air conditioners containing R290 - Risk of fire | DiversiTech (Pump House Ltd) have identified a manufacturing defect in some PAC12 and
PAH12 portable air conditioners that could cause fire. The manufacturer has confirmed a small
number of fires in Europe and has instigated a product recall of affected units. | 20/12/2021 |
| Select | NICAS-1019 | DSI/2021/009 | Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning | Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices. | 24/11/2021 |
| Select | NICAS-1017 | NISN-2021-001 | Portex - clear cuffed nasal endotracheal tube - Model No. 100/150/070 | We have been made aware of an incident were ICU staff have noticed that the Portex - clear cuffed nasal endotracheal tube (model No. 100/150/070 all sizes) are more prone to kinking during long-term invasive ventilation (i.e. intubation). The Portex model No. 100/150/070 was distributed as an alternative to the previously used Rusch (Teleflex) devices due to a shortage in supplies. | 21/10/2021 |
| Select | NICAS-1014 | DSI-2021-008 | Medical devices sterilised by Steril Milano – potential for incomplete sterilisation | Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks. | 30/06/2021 |
| Select | NICAS-1013 | NatPSA-2021-005MHRA | Philips ventilator, CPAP and BiPAP devices | Potential for patient harm due to inhalation of particles and volatile organic compounds.
These devices are primarily used in patients with Obstructive Sleep Apnoea (OSA) and type 2 respiratory failure
There is a risk of patient harm from degradation of the sound abatement foam found in these devices.
Reports of incidents related to this issue are rare, and no incidents of harm have been reported in the UK.
Further supporting information to support HSC Trusts in their handling of the actions and to support patient engagement is in preparation and will be issued in due course. | 23/06/2021 |
| Select | NICAS-1008 | MDSI-2021-009 | BD Venflon Pro Safety (VPS) Needle Protected IV Cannula - Product Recall Extended to further catalouge numbers | In March 2021 An advisory Field Safety Notice was issued by BD to advise users of the potential that the device may exhibit leakage from the injection port. This was followed by advice and the reissue of the FSN under MDSI-2021-007 issued on the 4th May 2021.
The information in MDSI-2021-009 and its attached FSN supersedes and extends the product catalogue numbers provided in MDSI-2021-007.
It should be noted that MHRA has separately published UK specific advice relating to this Field Action: Alerts and recalls for drugs and medical devices - GOV.UK (www.gov.uk).
Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.
Change made:
The manufacturer has extended the recall to also include specific catalogue numbers the BD Venflon Pro IV Cannula.
| 20/05/2021 |
| Select | NICAS-1012 | MDSI-2021-008 | Investigation update: CE mark suspended for all MAGEC systems manufactured by NuVasive | Investigation update: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc.
The MHRA’s investigation has identified several deficiencies with the technical documentation relating to MAGEC systems and NSO’s quality management system. The MHRA sent its initial findings to NSO and their EU Notified Body in September 2020. Following this report, the Notified Body undertook its own review, which resulted in the CE certificate being suspended on 25 March 2021. Additional details on MHRA’s investigation will be communicated in due course.
It is important that your organisation takes the actions detailed in the FSN. Confirm that you have received the FSN by returning the slip on page 3 of the FSN | 10/05/2021 |
| Select | NICAS-1011 | MDSI-2021-007 | BD Venflon Pro Safety (VPS) Needle Protected IV Cannula - Product Recall | In March 2021, An advisory Field Safety Notice was issued by BD to advise users of the potential that the device may exhibit leakage from the injection port.
The information in this Field Safety Notice supersedes the information provided in March 2021.
It should be noted that MHRA has separately published UK specific advice relating to this Field Action: Alerts and recalls for drugs and medical devices - GOV.UK (www.gov.uk). | 04/05/2021 |
| Select | NICAS-1009 | MDSI-2021-006 | Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue | Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal. | 20/04/2021 |
| Select | NICAS-1006 | NIA-2021-001 | Reporting of Medical Device and Estates Adverse Incidents and distribution of information | Reporting of Medical Device and Estates Adverse Incidents and disseminating safety information distributed by the NIAIC | 12/04/2021 |
| Select | NICAS-1007 | MDSI-2021-005 | Dexcom G6 Sensor: untested barrier methods to reduce skin reactions | Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor. | 07/04/2021 |
| Select | NICAS-1005 | MDSI-2021-003 | The use and regulation of pulse oximeters | Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices | 29/03/2021 |
| Select | NICAS-1003 | MDSI-2021-004 | Device Safety Information - Chirana T. Injecta | Medoject Sterile Hypodermic and Blunt fill needles manufactured by Chirana T. Injecta – potential presence of black residue on needles, discontinue use. | 29/03/2021 |
| Select | NICAS-1004 | MDSI-2021-002 | BD Customer Update on the supply disruption of sterile infusion sets and connectors | Customer update and guidance on how to validate impacted sets. | 23/03/2021 |
| Select | NICAS-1002 | NatPSA-2021-001-MHRA | Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) | Becton Dickinson (BD) have notified MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider. BD is recalling all affected stock of the following products:
• Infusion sets for specific Alaris pumps
• Gravity infusion sets and connectors
| 11/03/2021 |
| Select | NICAS-1001 | MDSI-2021-001 | Paclitaxel drug-coated balloons or drug-eluting stents | Paclitaxel drug-coated balloons or drug-eluting stents - Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia. | 22/02/2021 |
| Select | NICAS-998 | DB-2021-005 | Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use | MHRA Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use - February 2021, version 4.3 | 05/02/2021 |
| Select | NICAS-997 | DB-2021-004 | Management and use of IVD point of care test - version 1.2 | The aim of this document is to provide advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. It is a revised edition of the version first published in 2002 as DB 2002(03). | 04/02/2021 |
| Select | NICAS-994 | DB-2021-002 | Single-use medical devices - implications and consequences of reuse V2.4 | Single-use medical devices - implications and consequences of reuse V2.4 | 01/02/2021 |
| Select | NICAS-995 | DB-2021-003 | Management of In Vitro Diagnostic Medical Devices | Guidance on the Management of In Vitro Diagnostic Medical Devices (IVD), their safety, quality and performance. | 01/02/2021 |
| Select | NICAS-992 | DB-2021-001 | Safe use of bed rails - January 2021 Version 4.0 | Guidance on managing and using bed rails safely. | 15/01/2021 |
| Select | NICAS-991 | MDSI-2020-002 | MRI guidance for patients with gastric bands | The MHRA has become aware that there is potential for harm when patients implanted with gastric bands containing metallic components undergo MRI. Some models of gastric bands may contain a metallic component as part of their device design. | 23/12/2020 |
| Select | NICAS-988 | MDSI-2020-001 | T34 ambulatory syringe pumps | Joint statement on the on-going work to resolve issues with T34 ambulatory syringe pumps | 09/11/2020 |
| Select | NICAS-987 | MDSB-20-02 | Medical Device Safety Bulletin - 2020 - No.2 | Current issue identified by the MHRA | 05/11/2020 |
| Select | NICAS-986 | NIA-2020-004 | Recirculation of Medical Device Alert MDA-2015-0018 | Following the recent reporting of near miss incidents involving posture and safety belts, the attached alert is being recirculated as a timely reminder | 22/10/2020 |
| Select | NICAS-985 | MDSB-20-01 | Medical Devcie Safety Bulletin - 2020 - No.1 | The MHRA are no longer issuing Medical Device Alerts (MDA), but will issue serious safety concerns via the National Patient Safety Alerts (NatPSA). This Medical Device Safety Bulletin (MDSB) is a pilot for a regular bulletin from MHRA to inform health and care professionals in the UK of new or ongoing safety issues with medical devices and will be published on a fortnightly basis. To help ensure the safety of patients, we recommend you read this bulletin and act on any aspects that affect your practice or the care you provide. The MHRA are collecting feedback and data on this new bulletin and will use it to evaluate and develop this communication tool. | 19/10/2020 |
| Select | NICAS-984 | NIA-2020-003 | Changes to MHRA alerts | From now on, all safety-critical alerts for medicines and medical devices that require a response will be issued under the National Patient Safety Alert format. These alerts follow the criteria and template agreed by the National Patient Safety Alerting Committee (NaPSAC). | 25/09/2020 |
| Select | NICAS-983 | NatPSA-2020-007-MHRA | Philips V60 Ventilators May Shut Down Unexpectedly Due to a Premature | Manufactured by Philips Respironics – sudden loss of power due to component failure, which may not always be accompanied by an alarm or visual warning. | 24/09/2020 |
| Select | NICAS-981 | MDA-2020-022 | Philips Sterilizable Defibrillator Internal Paddles (all models) | Manufactured by Philips – Defibrillator Internal Paddles may wear over time and may fail to deliver therapy, unless the Instructions for Use to perform routine operational checks are followed after each sterilisation cycle. | 23/07/2020 |
| Select | NICAS-982 | MDA-2020-021 | Masks: type IIR from Cardinal Health – destroy affected lots | Supplied by Cardinal Health – foam strip on the mask can flake and enter the wearer’s airway or mouth; ties and/or stitching may detach from the mask. | 20/07/2020 |
| Select | NICAS-978 | MDA-2020-020 | Spinal fixation system – risk of breakage prior to completion of bone healing | Manufactured by Depuy Synthes – breakage of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing. | 10/07/2020 |
| Select | NICAS-980 | MDA-2020-019 | Abbott Trifecta/Trifecta GT bioprosthetic aortic heart valves structural valve deterioration. | Manufactured by Abbott – cases of valvular insufficiency and early revision.
| 06/07/2020 |
| Select | NICAS-979 | MDA/2020/018 | The Philips HeartStart XL Defibrillator/Monitor - therapy selector switch may fail | The Philips HeartStart XL Defibrillator/Monitor’s rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy. This alert is distributed in Northern Ireland for information only as there are no known affected devices supplied to the Region. | 30/06/2020 |
| Select | NICAS-977 | MDA-2020-017 | V60 ventilator – Potential unexpected shutdown leading to complete loss of ventilation | Manufactured by Philips Respironics – loss of power due to component failure this may not always be accompanied by an alarm or visual warning. | 29/06/2020 |
| Select | NICAS-974 | MDA/2020/016 | Philips HeartStart MRx Monitor/Defibrillators may fail to deliver therapy without alerting the user. | The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock. | 17/06/2020 |
| Select | NICAS-976 | MDA-2020-015 | Results from laboratory-based tests for COVID19 antibodies using home blood sample collection kits m | Fingerprick blood sample collection kits and – unvalidated for home use.
Laboratory based tests for COVID19 antibodies – unvalidated sample type
Results from laboratory-based tests for COVID19 antibodies using home blood sample collection kits may not be reliable. | 08/06/2020 |
| Select | NICAS-975 | NIA-2020-002 | Risks associated with the use of Alcohol Based Hand Sanitisers | The wide spread use of Alcohol based hand sanitisers to control cross infection can increases the risk of fire and poisoning.
It should be noted that the benefits of using alcohol hand rubs are considerable and far outweigh the risks mentioned in this notice if adequate control measures are put in place.
This alert replaces MDEA(NI)2005/43 - Alcohol Based Hand Wash.
| 29/05/2020 |
| Select | NICAS-970 | MDA-2020-013 | Covid-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up | All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death. | 10/04/2020 |
| Select | NICAS-969 | MDA-2020-012 | Anaesthetic machines: off-label use during the COVID-19 pandemic | All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability. | 08/04/2020 |
| Select | NICAS-967 | MDA-2020-011 | Spinal implant: All MAGEC Systems – supply suspended to the UK | Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market due to uncertainty over the safety profile requiring further review. | 01/04/2020 |
| Select | NICAS-965 | MDA-2020-010 | Spinal implant - MAGEC System Model X rods – Risk of failure in use | Manufactured by NuVasive Inc. – risk of end cap separation after implantation. | 18/03/2020 |
| Select | NICAS-966 | DB 2006-06 V3 | Bed rails - management and safe use | Guidance on managing and using bed rails safely. | 11/03/2020 |
| Select | NICAS-963 | MDA-2020-008 | Various duodenoscope models – frayed elevator wires may cause lacerations to patients and users | Manufactured by Olympus – instructions for use now carry directions to inspect for frayed wires prior to and after use to improve the detection of damaged elevator wires.
Example:
Manufactured by ABC123 – may cause leakage of medication and require surgical intervention to remove the needle.
| 27/02/2020 |
| Select | NICAS-964 | MDA-2020-009 | Tympanic thermometers-revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 | Cardinal Health has revised the calibration period to 25 weeks instead of yearly, to ensure that they remain within their accuracy range and reduce the risk of misdiagnosis and/or delay to treatment. | 27/02/2020 |
| Select | NICAS-961 | MDA-2020-007 | All T34 and T34L (T60) ambulatory syringe pumps | Risk of under infusion and no alarm generated to alert the user | 25/02/2020 |
| Select | NICAS-959 | MDA-2020-006 | Peripheral Vascular Stents – risk of migration during | Manufactured by Cordis – instructions for use contain incorrect MRI compatibility information. | 13/02/2020 |
| Select | NICAS-958 | MDA-2020-005 | t:slim X2™insulin pump – defective A/C Power Adapters | Manufactured by Tandem Diabetes Care – risk of injury from electrical shock.
| 05/02/2020 |
| Select | NICAS-942 | EFA-2020-001 | Allergens Issues - Food Safety in the NHS | There have in recent months been in excess of 77 incidents relating to allergens which on investigation have revealed some consistent themes, relating to lack of information and/or communication regarding food allergens present in the food and/or details of the patient’s known food allergy. | 29/01/2020 |
| Select | NICAS-954 | MDA-2020-003 | Professional use defibrillator / monitor all HeartStart XL+ (Model number 861290) - risk of failure | Manufactured by Philips – due to hardware or software issues the device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level.
| 28/01/2020 |
| Select | NICAS-950 | NIA-2020-001 | Risks associated from Construction works and Aspergillis Fungi | This Alert is to inform you of the potential dangers from the release of aspergillus fungi spores into the environment near vulnerable patients. Aspergillosis is a serious and often fatal disease.
There has been recent cases of invasive aspergillosis in an HSC Trust. Investigations are ongoing as to the source however, it is known that building works can increase this risk.
| 17/01/2020 |
| Select | NICAS-951 | MDA-2020-001 | NIPPY ventilator range (all models) – update to instructions for use | Manufactured by Breas Medical Limited – Maintenance schedule now includes changing the internal memory/alarm battery every 3 years. | 15/01/2020 |
| Select | NICAS-947 | MDA-2019-044 | BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking | Manufactured by Flexicare – loose bearings and retaining ring may enter patient’s airway causing choking hazard. | 12/12/2019 |
| Select | NICAS-945 | MDA/2019/041 | Spectra Optia Apheresis sets with ‘Correct Connect’ Anticoagulant connectors | Manufactured by Terumo – inadequately broken connector may lead to clotting and inadequate therapy | 04/12/2019 |
| Select | NICAS-943 | MDA/2019/040 | Alaris Gateway Workstation and Alaris Gateway Workstation Web Browser User Interface | Manufactured by Becton Dickinson – identified product security vulnerability which if
exploited may allow an attacker with malicious intention to remotely install unauthorized firmware
| 27/11/2019 |
| Select | NICAS-941 | MDA-2019-039 | Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart | Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy. | 31/10/2019 |
| Select | NICAS-929 | EFA-2019-005 | Issues with doorstops/door buffers | The use of door stops and door buffers in health care settings may present a hazard resulting in a risk of harm to patients. A door stop is a common term for all fixtures that protect or restrict a door operating freely, see ‘Device Details’ section for list of definitions. This EFA will use ‘door stop’ to cover all types and functions. | 31/10/2019 |
| Select | NICAS-940 | MDA-2019-038 | Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released | Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102). | 29/10/2019 |
| Select | NICAS-937 | MDA-2019-037 | Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment | Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown. | 10/10/2019 |
| Select | NICAS-938 | MDA-2019-034 | Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) | Manufactured by Ecolab/Microtek Medical Malta Ltd – bacterial contamination may cause an infection in patients. | 09/10/2019 |
| Select | NICAS-936 | MDA-2019-033 | Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit | Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury. | 08/10/2019 |
| Select | NICAS-934 | MDA-2019-032 | Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use | Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered. | 03/10/2019 |
| Select | NICAS-932 | EFA-2019-004 | Zebra printer Power Supply Units (PSUs): fire risk – product recall expanded | A defect present in PSUs supplied for certain models of printer manufactured by Zebra can lead to overheating or a fire hazard. Zebra has expanded an earlier product recall | 19/09/2019 |
| Select | NICAS-931 | MDA-2019-030 | All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress. | Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices. | 18/09/2019 |
| Select | NICAS-926 | MDA-2019-028 | Microneedling pens: Dermapen 3 and Dermapen Cryo sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection | Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios – do not use affected devices as they have been manufactured to unknown standards and their safety cannot be verified. | 27/08/2019 |
| Select | NICAS-928 | MDA-2019-027 | Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate | Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured. | 25/07/2019 |
| Select | NICAS-927 | MDA-2019-026 | Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes | Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results. | 24/07/2019 |
| Select | NICAS-924 | MDA-2019-025 | IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low | Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment. | 02/07/2019 |
| Select | NICAS-923 | MDA-2019-024 | Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required | Manufactured by BBraun Medical – dialysis fluid temperature may be outside of programmed range during treatment | 26/06/2019 |
| Select | NICAS-922 | MDA-2019-023 | Recommendations for paclitaxel drug coated balloons (DCBs) & implantable drug eluting stents (DESs) | Recommendations are provided regarding the use of paclitaxel drug coated balloons (DCBs) and drug eluting stents (DESs) following publicised concerns over an increase in patient mortality from two years after treatment. | 04/06/2019 |
| Select | NICAS-918 | MDA-2019-019 | Ethicon Curved Intraluminal Staplers – risk of failure of staple lines | Manufactured by Ethicon – use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding. | 25/04/2019 |
| Select | NICAS-913 | MDA-2019-018 | Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment | Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump. | 29/03/2019 |
| Select | NICAS-912 | MDA-2019-017 | Pagewriter Cardiographs & Efficia Monitors - risk of batteries overheating or igniting | Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
This applies to Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018. | 20/03/2019 |
| Select | NICAS-909 | MDA-2019-015 | enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device | Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels. | 08/03/2019 |
| Select | NICAS-911 | MDA-2019-014 | All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed | Manufactured by C.R. Bard (Becton, Dickinson and Company (BD)) – surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) is being withdrawn from hospitals and distribution centres. | 07/03/2019 |
| Select | NICAS-895 | EFA-2019-002 | Ingestion of Cleaning Chemicals | In a recent one-year period there have been eighteen incidents including one death reported to NHS Improvement where patients have ingested cleaning chemicals. This alert aims to clarify existing guidance and emphasises the importance of considering multiple factors in assessing risk to both staff and patients when using these products. | 28/02/2019 |
| Select | NICAS-904 | MDA-2019-009 | Accu-Chek Insight insulin pumps – some need to be fitted with key frames to reduce risk of accidentally unlocking keys or pressing the bolus buttons | Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump. | 19/02/2019 |
| Select | NICAS-903 | MDA-2019-008 | Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy | Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing. | 13/02/2019 |
| Select | NICAS-900 | MDA-2019-005 | Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination | Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results. | 31/01/2019 |
| Select | NICAS-899 | MDA-2019-004 | Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts WITHOUT a scale | Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient. | 30/01/2019 |
| Select | NICAS-897 | MDA-2019-003 | FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive | Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance | 29/01/2019 |
| Select | NICAS-896 | MDA-2019-001 | Datex-Ohmeda Aisys CS2 & Aisys anaesthesia devices - Risk of ventilation loss, inadequate anaesthesia, hypoxia, severe hypotension | Manufactured by GE Healthcare – Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension.
Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control. | 17/01/2019 |
| Select | NICAS-884 | EFA-2019-001 | Portable fans in health and social care facilities: risk of cross infection | Portable fans used in clinical areas have been linked to cross infection in health and social care facilities. Each use and reuse should be clinically risk assessed. Local procurement, cleaning, decontamination and maintenance policies must be produced and kept under review. | 11/01/2019 |
| Select | NICAS-893 | NIA-2019-001 | Reporting of Medical Device and Estates Adverse Incidents and disseminating Alerts | Reporting of Medical Device and Estates Adverse Incidents and disseminating Alerts | 09/01/2019 |
| Select | NICAS-891 | MDA-2018-037 | Fabian +nCPAP evolution and Fabian Therapy evolution – Risk of total loss of patient ventilation | Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input or alarm | 21/12/2018 |
| Select | NICAS-886 | EFA-2018-007 | Fire risk from personal rechargeable electronic devices | Personal rechargeable electronic devices present a fire risk during use and when being charged.
This alert supersedes and replaces EFA/2014/002 E-cigarettes, batteries and chargers. | 05/12/2018 |
| Select | NICAS-890 | MDA-2018-036 | Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power. | Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure. | 29/11/2018 |
| Select | NICAS-888 | MDA-2018-035 | All T34 ambulatory syringe pumps – update concerning battery information | Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump. | 14/11/2018 |
| Select | NICAS-885 | EFA-2018-006 | Vernacare Vortex macerator: potential for contamination of mains water supply | We have been informed that Vernacare Vortex Macerators, supplied under WRAS approval number 1309094, do not comply with the requirements of the UK Water Supply (Water Fittings) Regulations (Byelaws in Scotland). A polythene silencer tube fitted to the water tank inlet float valve means that the air gap is not maintained between the water tank contents and the mains water supply thereby creating the potential for contamination of the mains water supply by the tank contents | 22/10/2018 |
| Select | NICAS-882 | HE1/18/136232 | Reporting Medical Device and Estates Adverse Incidents | Revised guidance on reporting Medical Device and Estates Adverse Incidents to the Northern Ireland Adverse Incident Centre. This document replaces the Oct 2017 version of Reporting Medical Device and Estates Adverse Incidents'. | 03/10/2018 |
| Select | NICAS-883 | HE1/18/216528 | NIAIC Adverse Incident Form | Updated Word and PDF versions of the NIAIC reporting form for Adverse Incidents. This version incorporates the revised email address for NIAIC and includes a link to our Privacy Notice. | 03/10/2018 |
| Select | NICAS-877 | MDA-2018-030 | Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation | Manufactured by Halyard Health – risk of Flex Connector in Closed Suction Kits becoming loose or disconnecting, which may interrupt patient ventilation. | 19/09/2018 |
| Select | NICAS-879 | MDA-2018-031 | SureSigns VS & VM patient monitors and Viewing stations- risk of batteries overheating or igniting | Manufactured by Philips – Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting | 19/09/2018 |
| Select | NICAS-838 | EFA-2018-005 | Assessment of Ligature Points | Following the death of a patient using a ligature at a height of less than one metre, it has been highlighted in a Coroner’s Regulation 28 report that the learning should be shared and mitigations put in place irrespective of the height of the ligature
| 19/09/2018 |
| Select | NICAS-871 | EFA-2018-004 | Integrated Plumbing System (IPS) Panels - risk of accidental detachment | A number of adverse incident reports have been received where IPS Panels have detached
accidentally from the wall and fallen. In two of the reported incidents, injuries were received to persons that required clinical attention. In all reported incidents the panels were only retained with concealed plastic push fit clips. | 22/08/2018 |
| Select | NICAS-872 | MDA-2018-027 | Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL) | UK update on BIA-ALCL | 26/07/2018 |
| Select | NICAS-855 | EFA-2018-003 | Fire in multi-storey car parks (MSCPs) | A fire at the Liverpool Echo Arena MSCP in December 2017 was exceptional in scale because the original fire in one car quickly spread to other cars. It is possible that similar events could occur again, and all health boards / trusts and local authorities with MSCPs should be aware of the hazards and manage the associated risks. In February 2017 Structural-Safety’s Standing Committee on Structural Safety (SCOSS) published an alert on the fire (see Reference section or annex for copy of alert). | 02/07/2018 |
| Select | NICAS-862 | EFA-2018-002 | Andrews Water Heaters Direct Fired Domestic Hot Water Heaters - inspections/modifications required | Andrews Water Heaters has identified some instances on selected models where the pipe connections have shown signs of corrosion.
Our investigations have determined that the zinc coating on the fittings may be insufficient to protect the mild steel from water, and that water may seep in between the unsealed plastic sleeve inside the nipple and the nipple itself, and where it is trapped it could cause corrosion.
| 18/06/2018 |
| Select | NICAS-859 | MDA-2018-018 | Various Arrow Critical Care devices – recall due to incomplete packaging seals | Manufactured by Teleflex – various critical care devices manufactured from January to December 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection. | 31/05/2018 |
| Select | NICAS-856 | EFA-2018-001 | GCE regulators type MPRS2 used in medical, laboratory and industrial gas cylinder supply manifold systems: risk of catastrophic failure | A metal structure fault in a batch of bonnet components for GCE regulators can result in catastrophic fracture failure of the bonnet under certain operating conditions. (See figures 2, 3, 4 and 5 from reports from different NHS Trusts). This results in the regulator ceasing to supply working gas and the possibility of physical injury from ejected components.
The regulators at risk were manufactured in 2015, and bear the data codes: E5AA, E5BA, E5CA, E5DA, E5EA, E5FA, E5GA, E5HA, E5JA, some may have ‘F’ as the last letter. The code is marked on the rear of the regulator, see figure 1. | 29/05/2018 |
| Select | NICAS-854 | MDA-2018-015 | Gambro Ultrafilter U9000 microbial water filter for haemodialysis – risk of hypovolemia due to filter leaks during use | Manufactured by Baxter Healthcare – Updated instructions for use regarding filter lifespan as cracks may develop after repeated disinfection cycles | 16/05/2018 |
| Select | NICAS-845 | MDA-2018-008 | Aquilon series of nebulisers – CE mark withdrawn and supply ceased | Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified. | 22/02/2018 |
| Select | NICAS-843 | MDA-2018-006 | Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment | Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm. | 15/02/2018 |
| Select | NICAS-837 | MDA-2018-002 | All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries | The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfilment of orders for new batteries. | 15/01/2018 |
| Select | NICAS-839 | MDA-2018-001 | Pacemakers & CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope & pre-syncope | Manufactured by Boston Scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal
| 12/01/2018 |
| Select | NICAS-833 | EFA-2017-006 | Supply of CNA 2000 pipeline gaskets: presence of asbestos | A Health and Safety Executive (HSE) investigation revealed that G&H Engineering Services manufactured CNA 2000 pipeline gaskets containing asbestos between 2006 and 2010. G&H Engineering Services alerted their customers by letter in 2011 but affected gaskets have subsequently been located in healthcare premises. HSE wrote to potential customers directly on 30 October 2017 (see appendix for copy of letter) to highlight the issue. | 07/12/2017 |
| Select | NICAS-819 | EFA-2017-005 | Unbranded LED decorative lighting chains, model CL100: risk of electric shock due to inadequate construction – remove from use | There is a risk of electric shock due to inadequate construction of unbranded LED decorative lighting chains. Implicated units should be immediately removed from use in health and social care premises.
This risk was highlighted via the EU Rapid Reaction System (RAPEX) and Electrical Safety First issued a recall on 4 August 2017. No contact details were available for the manufacturer. This may mean there is no proper legal representative for the products, and the supply chain may be undocumented. | 21/11/2017 |
| Select | NICAS-825 | EFA-2017-004 | Safety Inspection Required of Armitage Shanks A4129AA Contour 21 Thermostatic Built In Shower valve | Ideal Standard has identified circumstances in which the shower can deliver water exceeding the commissioned 41°C bathing temperature. Safety inspections are required, with remedial action where necessary. | 25/10/2017 |
| Select | NICAS-831 | HE1/17/113361 | Reporting Medical Device and Estates Adverse Incidents | Revised guidance on reporting Medical Device and Estates Adverse Incidents to the Northern Ireland Adverse Incident Centre. This document replaces DB2010(NI)-01 - Reporting adverse incidents and disseminating alerts - revised Feb 2015 | 13/10/2017 |
| Select | NICAS-824 | NIA-2017-001 | Risks associated with nitrous oxide waste gases | Nitrous Oxide gas can present a health risk to staff, when control measures do not reduce the level of gas to or below the Workplace Exposure Limits (WELs), required to comply with the COSHH regulations. All areas where Nitrous Oxide gas is used should be subject to a Multi Disciplinary Risk Assessment to identify the risks and control measures required. | 07/09/2017 |
| Select | NICAS-805 | EFA-2017-003 | Guidance for correct use and disposal of batteries | The use and incorrect disposal of batteries may result in equipment/devices emitting smoke and fumes, not functioning normally, quickly running out of power, being permanently damaged and, in certain circumstances, there may be a fire. | 06/09/2017 |
| Select | NICAS-821 | MDA-2017-028R | Replacement bileaflet mechanical heart valves – risk of inverted implantation | *Please ignore previous emails and versions of this MDA. This alert was issued on CAS at 14:05 and is a re-issue of MDA/2017/028. The attached PDF is the final and only version which should be published. This version still has the original publishing time on it but has had headers removed and been renamed MDA/2017/028R. Please forgive any confusion or inconvenience caused.
Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder | 31/08/2017 |
| Select | NICAS-807 | EFA-2017-002 | Anti-barricade devices: risk of ineffectivity in certain circumstances | Anti Barricade devices may have been fitted to doors to manage the risk of barricade situations occurring. Some of these devices may be rendered ineffective in certain circumstances. This increases the risk of avoidable harm and self harm until the room can be accessed. | 21/08/2017 |
| Select | NICAS-816 | MDA-2017-023 | Zimmer Biomet Comprehensive Nano Humeral Components: Increased risk of revision when used in reverse configuration | Manufactured by Zimmer Biomet – The affected Comprehensive Nano Humeral Components should not be used in the reverse configuration. The component may still be used in the anatomic configuration. | 18/08/2017 |
| Select | NICAS-813 | MDA-2017-022 | DePuy Synthes Impactor for PFNA (Proximal Femoral Nail anti-rotation) Blade: risk of infection | Manufactured by DePuy Synthes GmbH – Recall due to risk of infection from cracked weld of the handle. | 17/08/2017 |
| Select | NICAS-812 | MDA-2017-020 | Haemofiltration machine: Prismaflex software version 6.10 - risk of under-infusion of anticoagulant | Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings. | 11/07/2017 |
| Select | NICAS-810 | MDA-2017-018 | Metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients with these devices | MHRA is updating the patient follow-up advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements. | 29/06/2017 |
| Select | NICAS-808 | MDA-2017-016 | DePuy-Synthes Radial Head Elbow Prosthesis System, Risk of Post-Operative Loosening of Radial Stem | Recall of Radial Head Prosthesis System Manufactured by DePuy-Synthes due to risk of post-operative loosening of the radial stem at the stem bone interface.
Associated Radial Head Prosthesis system parts also need to be returned to DePuy Synthes but will be available for revision surgeries of the radial head component. | 12/06/2017 |
| Select | NICAS-804 | MDA-2017-014 | HeartStart MRx Defibrillator – possible failure to shock, cardioversion, pacing or monitoring | Manufactured by Philips Healthcare, the device may fail to power on or may exhibit repetitive reboot if operating on battery power only. | 24/05/2017 |
| Select | NICAS-803 | MDA-2017-013 | All LIFEPAK 1000 automatic external defibrillators (AED) - risk of failure to deliver a shock. | Manufactured by Physio-Control – risk of unexpected device shut down due to an intermittent connection between the battery and device contacts. | 18/05/2017 |
| Select | NICAS-800 | MDA-2017-011 | Biological replacement pericardial aortic heart valve. MitroFlow LX (sizes 19mm & 21mm). | There is an increased risk of earlier than anticipated structural valve deterioration (SVD), particularly with the smaller sizes. | 03/05/2017 |
| Select | NICAS-796 | MDA-2017-006 | All Alaris™ GS, GH, CC, TIVA, PK, enteral syringe pumps & Asena™ GS, GH, CC, TIVA, PK, syringe pumps – risk of uncontrolled bolus of medicine. | Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps. • Note that this alert replaces MDA/2017/003, which we published in February 2017. | 12/04/2017 |
| Select | NICAS-795 | MDA-2017-005 | Comprehensive Reverse Titanium Shoulder Tray (specific lots) - risk of device fracture | Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017. | 04/04/2017 |
| Select | NICAS-789 | EFA-2017-001 | Swimming pool overhead lighting systems | The findings from the Health and Safety Executive and Local Authority investigations indicate that the plastic bracket / roller system, found on a certain type of aluminium lighting system which operates on a runner, is liable to severe degradation over time and can break and collapse without warning. | 31/01/2017 |
| Select | NICAS-784 | EFA-2016-005 | Recall of Hager 10kA Miniature Circuit Breakers (MCBs) | Hager have identified a material non conformity which could affect the correct functioning of their 10kA MCBs and have issued a product recall for specific references. These devices may have been installed on some healthcare sites, or may be held in stock, and the recall notice is being shared to achieve further penetration within healthcare estates. | 24/11/2016 |
| Select | NICAS-783 | MDA-2016-021 | Total intravenous anaesthesia sets (TIVA) – risk of leakage during use. | Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery. | 27/10/2016 |
| Select | NICAS-782 | MDA-2016-020 | Managing diabetes: patients should not change their insulin delivery device without checking with their healthcare specialist. | All medical devices for the management of Type 1 diabetes - If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypoglycaemia or diabetic ketoacidosis. | 26/10/2016 |
| Select | NICAS-781 | MDA-2016-019 | Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) | Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy. | 17/10/2016 |
| Select | NICAS-779 | NIA-2016-005R | Introduction of the Northern Ireland Central Alert System (NICAS) | This is a new system to replace the Safety Alert Broadcast System (SABS). | 12/10/2016 |
| Select | NICAS-778 | MDA-2016-016 | Accu-Chek Insight insulin pump system – risk of over- or under-infusion of insulin | Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis. | 02/09/2016 |
| Select | NICAS-770 | NIA-2016-004 | End of MHRA derogation | End of MHRA derogation for US Baxter (2C8541) IV administration sets on: Tuesday 9th August 2016 | 25/07/2016 |
| Select | NICAS-769 | EFA-2016-004 | Operating Theatre Ultra Clean Ventilation (UCV) canopies fitted with gel seal HEPA filters | Several incidents have occurred involving gel seal HEPA filters fitted to Ultra Clean Ventilation (UCV) canopies. Gel from the HEPA filter seal dripped from the UCV canopy diffuser screen. In one case, gel dripped onto a patient during a surgical procedure.
| 21/07/2016 |
| Select | NICAS-768 | EFA-2016-003 | Metal waste pipes used for the disposal of laboratory solutions and reagents containing sodium azide | Sodium azide solutions disposed to waste through metal waste pipes may form metal azide reaction products. These products may accumulate in the pipes and explode if subjected to heat or mechanical shock, e.g. plumbing work. The risk of explosion may remain after the use of sodium azide solutions has ceased.
| 04/07/2016 |
| Select | NICAS-766 | EFA-2016-002 | 13A electrical socket inserts (socket covers or protectors) | In certain circumstances, the use of plastic 13A electrical socket inserts (sold as safety accessories), can overcome the safety features designed into socket outlets.
| 30/06/2016 |
| Select | NICAS-760 | EFA-2016-001 | Carbon steel press fit pipes for water heating systems - rapid corrosion and failure | "Carbon steel press fit pipes for water heating systems: rapid corrosion and failure.
There has been an increase in the use of thin-wall low carbon steel press-fit pipe work for new installations of water heating systems. It has been found that this pipework may be susceptible to rapid corrosion as a result of the introduction of air." | 04/05/2016 |
| Select | NICAS-758 | NIA-2016-003 | Addition useage of the Baxter Non CE marked device - Ref US 2C8541 | The use of the Non CE marked US 2C8541 Device as a Temporary Replacement for Additional Baxter IV Administration Sets | 23/03/2016 |
| Select | NICAS-756 | NIA-2016-002 | Supply of Non CE marked Baxter IV Administration Sets | "Further to Alert (NIA-2016-001), Baxter cannot meet current demand for the CE Marked Colleague
Pump compatible and gravity IV administration sets. . Baxter has received a derogation from the UK
competent authority (the MHRA) to supply non CE marked equivalent Colleague Pump compatible IV
administration sets to alleviate these supply issues.
The derogated device, code 2C8541, is the US equivalent to the UK set, code EMC9608. The US
2C8541 device must only be used with the Colleague pump for IV administration as there are differences in product design which affect its use as a gravity administration set." | 08/03/2016 |
| Select | NICAS-755 | MDA-2016-002 | Ambulatory syringe pumps (T34 and T60) and syringe extension sets | "Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).
CME has recommended the need for protection of these pumps when exposed to direct sunlight.
In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps." | 03/03/2016 |
| Select | NICAS-754 | NIA-2016-001 | Baxter IV Administration Sets – Supply Disruption | Baxter IV Administration sets (Colleague pump compatible and gravity) will be subject to limited availability across the product range until May 2016 with the potential for impact on the delivery of life saving care. | 18/02/2016 |
| Select | NICAS-750 | MDA-2015-038 | Cardiac Resynchronization Therapy Pacing (CRT-P) – Risk of loss of pacing therapy Medtronic InSync I | "Cardiac Resynchronization Therapy Pacing (CRT-P) – Risk of loss of pacing therapy
Medtronic InSync III. Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy." | 09/12/2015 |
| Select | NICAS-748 | EFA-2015-006 | Fire door self-closing devices | "Fire door self-closing devices.
A recent incident occurred where, during an electrical storm, the hospital power supply was momentarily interrupted causing fire doors held open on magnetic detents to be released. The closing doors struck an elderly patient as they passed through the doors, causing them to fall, and sustain a serious head injury, which ultimately contributed to their death two weeks later.
The fire doors were a set of double swing cross-corridor doors with floor mounted closing devices. The door self-closing device was compliant with the relevant British Standard, BS EN 1154, and the doors functioned as intended, albeit at the faster end of the standard, with the resultant consequence." | 27/11/2015 |
| Select | NICAS-746 | EFA-2015-005 | Plug-in Switch Mode Power Supply | Plug-in Switch Mode Power Supply - Severe injury resulted to consultant and patient when an earth path was completed following damage to equipment. | 16/11/2015 |
| Select | NICAS-745 | MDA-2015-036 | Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate | Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate. Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda. | 15/10/2015 |
| Select | NICAS-743 | MDA-2015-034 | Implantable medical devices manufactured by SILIMED - lndustria de lmplantes Ltda | Implantable medical devices manufactured by SILIMED - lndustria de lmplantes Ltda. Temporary suspension of the CE certificate due to particles found on some devices. | 25/09/2015 |
| Select | NICAS-735 | MDA-2015-026 | Haemodialysis: CRIT-LINE® blood chamber - product code CL10021021.Manufactured by Fresenius USA Manu | "Haemodialysis: CRIT-LINE® blood chamber -product code CL10021021.
Manufactured by Fresenius USA Manufacturing Inc. / Hemametrics. Recall of all lots due to risk of blood loss caused by leakage at the blood chamber connection." | 21/07/2015 |
| Select | NICAS-734 | MDA-2015-025 | 1. TransWarmer infant transport mattress. 2. NovaPlus TransWarmer infant heat therapy mattress with | Recall due to risk of serious burn if device is used past its expiry date. Devices manufactured before May 2013 don’t have expiry dates or lot numbers on their packaging. | 06/07/2015 |
| Select | NICAS-733 | MDA-2015-024 | Metal-on-metal (MoM) hip replacements: Birmingham Hip™ Resurfacing (BHR) system (Smith & Nephew Orth | "Metal-on-metal (MoM) hip replacements:
Birmingham Hip™ Resurfacing (BHR) system (Smith & Nephew Orthopaedics). Higher than expected revision rate for certain patient groups implanted with the Birmingham Hip Resurfacing (BHR) system. Guidance provided on implantation and patient management." | 25/06/2015 |
| Select | NICAS-731 | MDA-2015-022 | Heater-cooler devices used during cardiac surgery: risk of infection with Mycobacterium species. All | Heater-cooler devices used during cardiac surgery: risk of infection with Mycobacterium species. All manufacturers. There is a low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used in conjunction with cardiopulmonary bypass machines. The cause of the infection may come from Mycobacterium-contaminated water in the heater-coolers. | 11/06/2015 |
| Select | NICAS-730 | EFA-2015-004 | Grundfos - Conlift Pumps | Grundfos - Conlift Pumps. Grundfos Pumps have issued a safety warning about an early model of its CONLIFT range of compact condensate pump, units produced up until week 47 in 2007 (inclusive). They have found that under certain conditions these pumps may cause a fire. Typically these pumps are used in domestic and commercial applications such as condensing boilers, air-conditioning, dehumidifiers and refrigerators. Please note this recall does not affect the current CONLIFT1 LS, CONLIFT1, CONLIFT2, or CONLIFT2 pH+ models or any CONLIFT manufactured after week 47 2007. | 10/06/2015 |
| Select | NICAS-724 | MDA-2015-018 | All posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment | "All posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment.
Using the wrong type of belt or a belt that isn’t fitted or adjusted properly can lead to serious injury or death of the person using the equipment." | 21/04/2015 |
| Select | NICAS-722 | EFA-2015-002 | Safe use of Liquid Drain Cleaners | Safe use of Liquid Drain Cleaners - Many commercially available drain solvents contain chemicals that produce an exothermic reaction when they come in contact with water. The heat generated by this reaction can raise the water temperature to above boiling point, producing steam. If the drain is not well ventilated, this can cause a pressure increase in the drainage system which has the potential to cause unexpected damage. | 15/04/2015 |
| Select | NICAS-706 | NIA-2015-001 | Reporting of Medical Device Adverse Incidents & Near Misses and disseminating Alerts | "Reporting of Medical Device Adverse Incidents & Near Misses and disseminating Alerts.
In the interests of patients, staff and visitor safety all regulated healthcare providers, Ophthalmic, Pharmaceutical & Dental practices and GP surgeries have a requirement to report Adverse Incidents (AIs) involving medical devices to the Department via the Northern Ireland Adverse Incident Centre (NIAIC). The aim of this reporting and any subsequent investigation is to identify learning that can be shared across all healthcare service providers and work towards reducing the chances of the incident reoccurring, thereby improving safety for all." | 16/02/2015 |
| Select | NICAS-707 | NIA-2015-002 | Reporting of Estates and Facilities Adverse Incidents & Near Misses and disseminating Alerts | "Reporting of Estates and Facilities Adverse Incidents & Near Misses and disseminating Alerts.
In the interests of patients, staff and visitor safety all regulated healthcare providers, Dental practices and GP surgeries have a requirement to report Adverse Incidents (AIs) involving engineering plant, infrastructure and non-medical devices to the Department via the Northern Ireland Adverse Incident Centre (NIAIC). The aim of this reporting and any subsequent investigation is to identify learning that will be shared across all healthcare service providers and work towards reducing the chances of the incident reoccurring thereby improving safety for all." | 16/02/2015 |
| Select | NICAS-705 | DB2010(NI)-01 v3.0 | REPORTING ADVERSE INCIDENTS AND DISSEMINATING MEDICAL DEVICE ALERTS | Reporting Adverse Incidents and Disseminating Medical Device Alerts. This publication provides guidance on the NIAIC’s voluntary adverse incident reporting system and encourages users to report adverse incidents involving medical devices. | 13/02/2015 |
| Select | NICAS-702 | EFA-2015-001 | Window blinds with looped cords or chains | "Window blinds with looped cords or chains.
All types.
Looped cords and chains on window blinds continue to present a strangulation hazard to children and vulnerable adults." | 25/01/2015 |
| Select | NICAS-692 | EFA-2014-003 | Window restrictors of cable and socket design | "Window restrictors of cable and socket design.
Certain window restrictor mechanisms, when ‘locked’, can be opened with commonly available flat bladed instruments as well as the ‘key’ provided." | 10/11/2014 |
| Select | NICAS-688 | MDA-2014-039 | TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy d | Risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013. | 07/10/2014 |
| Select | NICAS-686 | MDA-2014-037 | All medical devices. | All medical devices. Delays in acting on Field Safety Notices (FSNs) can compromise patient safety. MHRA is aware that FSNs sent by manufacturers are not always cascaded in an effective and timely manner to the relevant people that need to be aware of the reported problem and for the required actions to be carried out. MHRA often has to issue Medical Device Alerts (MDAs) reminding users about manufacturers’ FSNs where there is insufficient feedback that it has reached the appropriate people and been acted upon. | 26/09/2014 |
| Select | NICAS-684 | MDA-2014-035 | EllipseTM VR/DR implantable cardioverter defibrillators - ICDs | "EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).
Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.
Manufactured by St Jude Medical." | 16/09/2014 |
| Select | NICAS-677 | PSA-W-2014-013 | Risk Of Inadvertently Cutting In-Line Suction Catheters | "Risk Of Inadvertently Cutting In-Line (Or Closed) Suction Catheters.
An incident has occurred recently where an in-line (or closed) suction catheter was left in the endotracheal tube (ET tube) by mistake. When the ET tube was cut to reduce the dead space, the suction catheter was also cut and the tip remained in the ET tube. The incident was not noticed for several days and during this time the tip of the suction catheter migrated into the patient?s main bronchus. The tip was identified on a chest X-ray and subsequently removed by bronchoscopy." | 17/07/2014 |
| Select | NICAS-666 | NIA-2014-002 | Issues regarding the compatibility of needle free connectors when used in conjunction with Glass Syr | "Issues regarding the compatibility of needle free connectors when used in conjunction with Glass Syringes.
Recently the NIAIC have received an increased number of incident reports regarding blockages of syringes or the failure to administer drugs from pre-filled glass syringes.
As these syringes are potentially used on patients in life critical situations failure to administer drugs poses a serious risk health or death." | 06/06/2014 |
| Select | NICAS-665 | MDA-2014-020 | Heated humidifiers used in combination with heated-wire breathing systems. Various manufacturers. | "Heated humidifiers used in combination with heated-wire breathing systems. Various manufacturers. Risk of oxygen-fuelled fire if: alarms are ignored, damaged breathing systems are used.
The MHRA is aware of a fire caused by a damaged breathing system being used with an elevated oxygen concentration. The humidifier alarmed but the user silenced it and did not take any action." | 04/06/2014 |
| Select | NICAS-663 | MDA-2014-018 | Unicondylar sled knee prosthesis | "Unicondylar sled knee prosthesis
Metal-backed tibial plateau Endo-Model® 7mm Manufactured by Waldemar Link GmbH & Co. KG Catalogue numbers: 15-2030/01, 15-2030/05 and 15-2030/09.
Risk of early wear of the ultra high molecular weight polyethylene (UHMWPE) plastic part of the tibial plateau of this device." | 29/05/2014 |
| Select | NICAS-664 | MDA-2014-019 | Paradigm ambulatory insulin infusion pumps. Manufactured by Medtronic. | "Paradigm ambulatory insulin infusion pumps. Manufactured by Medtronic. Risk of hypoglycaemia due to incorrect selection and delivery of bolus amount.
Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount." | 29/05/2014 |
| Select | NICAS-660 | MDA-2014-015 | All temporary pacemakers and pacing system analysers (PSAs) manufactured by Pace Medical Inc | "All temporary pacemakers and pacing system analysers (PSAs) manufactured by Pace Medical Inc.
These devices are currently not on the EU market. Their CE-marking has been suspended because of quality system failings." | 15/05/2014 |
| Select | NICAS-657 | DB(NI)2014/02 | Managing Medical Devices | "Re-issue of Device Bulletin DB2006-05-V2 under DB(NI)2014/02
The Medicines and Healthcare Regulatory Agency (MHRA) have updated guidance on ""Managing Medical Devices"" which supersedes and replaces their previous published guidance." | 24/04/2014 |
| Select | NICAS-656 | DB2006-05-V2 | Managing Medical Devices | The Medicines and Healthcare Regulatory Agency (MHRA) have updated guidance on "Managing Medical Devices" which supersedes and replaces their previous published guidance | 23/04/2014 |
| Select | NICAS-654 | NIA-2014-001 | Publication of the MHRA and NHS England Patient Safety Alert – Stage 3 Directive Improved Medical De | "Publication of the MHRA and NHS England Patient Safety Alert – Stage 3 Directive
Improved Medical Device Reporting and Supporting Information. 20th March 2013. The MHRA and NHS England have issued a
Patient Safety Alert on Improved Medical Device Reporting and Learning and a supporting information booklet. This information relates to current ongoing work between the MHRA and NHS England to improve medical device reporting in England and subsequently improve
learning. While this alert and supporting information is labelled national it applies only to the NHS in England. The current reporting mechanisms for Medical Device Adverse Incidents in Northern Ireland as described in the guidance document
Device Bulletin 2010(NI) - 01 remain unchanged at this time." | 10/04/2014 |
| Select | NICAS-650 | MDA-2014-008 | Accu-Chek Spirit Combo insulin pump | "Accu-Chek Spirit Combo insulin pump
Manufactured by Roche Diagnostics Ltd.
All pumps with serial numbers in the range 10171897 to 10281629 (inclusive).
Risk of delay to treatment." | 11/03/2014 |
| Select | NICAS-646 | MDA-2014-005 | Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 (wall and ceiling mounted). Manufactured by | "Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 (wall and ceiling mounted)
Manufactured by Carestream Health. Models released for sale from May 2008 to April 2010, serial numbers as identified in the FSN. Risk of injury if the joint between the scissor arm and bracket fails. This joint could fail prematurely due to a manufacturing problem during the period from May 2008 to April 2010." | 24/02/2014 |
| Select | NICAS-645 | DB2010(NI)-01 v2.0 | REPORTING ADVERSE INCIDENTS AND DISSEMINATING MEDICAL DEVICE ALERTS | Reporting Adverse Incidents and Disseminating Medical Device Alerts. This publication provides guidance on the NIAICs voluntary adverse incident reporting system and encourages users to report adverse incidents involving medical devices. | 18/02/2014 |
| Select | NICAS-644 | MDA-2014-004 | Counterfeit or non-CE marked dental medical devices. | Counterfeit or non-CE marked dental medical devices. Counterfeit or non-CE marked dental medical devices bought online could fail during use with a risk of injury to patient and user. | 24/01/2014 |
| Select | NICAS-638 | MDA-2013-084 | Implantable pacemakers manufactured by Sorin. REPLY – models D, DR, VDR, SR ESPRIT – models D, DR, S | "Implantable pacemakers manufactured by Sorin. REPLY – models D, DR, VDR, SR
ESPRIT – models D, DR, S, SR. Risk of loss of pacing due to overestimation of the time remaining to elective replacement indicator (ERI)." | 19/12/2013 |
| Select | NICAS-633 | EFA-2013-004 | Review of Cold Water Storage Tanks | Cold Water Storage Tanks - The use of uncapped PVC-U pipes (or similar) within cold water tanks as a support structure for the lid is likely to lead to stagnation and harbouring of harmful micro-organisms. | 18/11/2013 |
| Select | NICAS-631 | MDA-2013-078 | Infusion pumps. Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser. Manufa | "Infusion pumps. Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare
PCA infuser. Manufactured by Hospira.
All models and list numbers." | 04/11/2013 |
| Select | NICAS-623 | NIA-2013-002 | All Fire Rated Glass supplied from a company called Glassworks Ireland Ltd and marked as Pyroguard. | "All Fire Rated Glass supplied from a company called ‘Glassworks Ireland Ltd’ and marked as Pyroguard. Counterfeit fire rated glass has been found on an HSC hospital site. The glass was marked
with a stamp bearing the names of Glass Works Ireland and Pyroguard. Customers of this glass may also have been supplied with an accompanying certificate which indicated that the glass was an authentic product from CGI International, the manufacturer of Pyroguard fire glass.
Pyroguard is a recognised, approved and
certified Fire Rated glass, however ‘Glassworks Ireland Ltd’ have not purchased this product from the manufacturer." | 29/08/2013 |
| Select | NICAS-612 | MDA-2013-060 | Wheeled and non-wheeled walking frames (all models). Manufactured by Patterson Medical. Batch codes | "Wheeled and non-wheeled walking frames (all models). Manufactured by Patterson Medical. Batch codes from DMW12013 to DMW82013 inclusive. Potential for detachment of the wheels and/or
inadequately tightened screws, which may
cause the user to fall. Frames of specific batches produced from January 2013 to March 2013 may not have been manufactured to specification. The manufacturer issued a Field Safety Notice
in May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information." | 01/08/2013 |
| Select | NICAS-605 | MDA-2013-053 | Intra-oral dental X-ray units-IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510. | "Intra-oral dental X-ray units - IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510. Manufactured by Trophy (now owned by Carestream Health). Models manufactured from November 1990 to November
1994 inclusive. Risk of injury from falling unit after failure of the wall mount bracket.
The devices were subject to a modification in 1995 and 2000 to address this risk. However, we have received a number of reports of device failure where the maintenance instructions have
not been followed, and the manufacturer has not been able to confirm that all affected devices have received the modification." | 18/07/2013 |
| Select | NICAS-602 | MDA-2013-045R | Philips - Biplane cardiovascular X-ray system | "Philips - Biplane cardiovascular X-ray system - Allura Xper FD10/10 Floor Mounted.
Risk of interruption in treatment/procedure due to an inability to move the table as the motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm." | 11/07/2013 |
| Select | NICAS-603 | NIA-2013-001 | Management of chemicals in Endoscopic Washer Disinfectors | "Management of chemicals in Endoscopic Washer Disinfectors.
Only detergents / disinfectants that have been type tested and validated for the EWDs and the Flexible Endoscopes that are being processed through them should be used.
Correct placement of these chemicals within the EWD is vital to the decontamination process and ensures the right chemical and dose is delivered at the appropriate point during the machine cycle." | 11/07/2013 |
| Select | NICAS-595 | MDA-2013-045 | Biplane cardiovascular X-ray system: Allura Xper FD10/10. Manufactured by Philips. All systems are a | "Biplane cardiovascular X-ray system:
Allura Xper FD10/10. Manufactured by Philips. All systems are affected. Risk of interruption in treatment/procedure due
to an inability to move the table. The table will reboot if users attempt a powered
and manual movement at the same time.
The reboot will take approximately 90 seconds during which time no motorised movement will be possible. This has led to delay during emergency treatment. Basic imaging will be available." | 24/06/2013 |
| Select | NICAS-592 | MDA-2013-042 | Implantable drug pumps and accessories - SynchroMed II and SynchroMed EL (all models) Sutureless con | Implantable drug pumps and accessories - SynchroMed II and SynchroMed EL (all models) Sutureless connector intrathecal catheter products (models 8709SC, 8731SC, 8596SC, 8578) Manufactured by Medtronic. Risk of drug under- or overdose due to various issues with these drug pumps. | 19/06/2013 |
| Select | NICAS-585 | MDA-2013-035 | Paradigm ambulatory insulin infusion pumps. Manufactured by Medtronic. | Paradigm ambulatory insulin infusion pumps. Manufactured by Medtronic. Models: MMT - 511, 512, 712, 712E, 515, 715, 522, 722, 722K, 523, 723, 723K, 554 (VEO) and 754 (VEO). Risk of compromised insulin therapy, which may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). The root causes are - Loose drive support cap (all models), Damage to pump if immersed in water (all models), Programming issue related to the sensor graph timeout (Paradigm VEO MMT-554 and MMT-754 only). | 17/05/2013 |
| Select | NICAS-582 | MDA-2013-032 | Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules. | "Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules. All manufacturers and all models. Risk of inadequate external pacing, leading to potential periods of asystole, syncope and possible death.
Factory default start-up pacing current and rate settings on transcutaneous pacemaker modules vary and may be too low to ensure pacing capture.
Users should be aware of this and ensure settings are configured to meet their local protocols. Transcutaneous pacing modules have factory defaults that initiate pacing with a low current and rate.
The MHRA has received a report that highlights the importance of raising awareness that the factory defaults can be configured to user presets.
Further guidance on trancutaneous pacing is being considered by Heart Rhythm UK (HRUK)." | 10/05/2013 |
| Select | NICAS-578 | MDA-2013-028 | Retrievable inferior vena cava (IVC) filters. All models and manufacturers | "Retrievable inferior vena cava (IVC) filters.
All models and manufacturers
Serious complications associated with attempted IVC filter retrieval.
This MDA updates and replaces MDA/2007/029 ‘Retrievable permanent inferior vena cava (IVC) filters’." | 02/05/2013 |
| Select | NICAS-568 | MDA-2013-019 | Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces. All manufac | "Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces. All manufacturers. Detergent and disinfectant wipes can damage plastic surfaces of medical devices if they are
not compatible with the surface material.
Damaged surfaces may compromise the ability to decontaminate medical devices adequately and / or may interfere with device function." | 27/03/2013 |
| Select | NICAS-569 | DB2010(NI)01 v2.0 | Reporting adverse incidents and disseminating alerts | "Reporting adverse incidents and disseminating alerts
This document is only for use with Northern Ireland" | 27/03/2013 |
| Select | NICAS-565 | MDA-2013-016 | GemStar infusion system | "Infusion pumps: GemStar infusion system.
Manufactured by Hospira.
All list numbers are affected
Pump faults may lead to over-infusion, low infusion rates or an interruption of infusion:" | 26/03/2013 |
| Select | NICAS-559 | MDA-2013-010 | Metal-on-metal (MoM) total hip replacements: ADEPT® 12/14 modular head (Finsbury Orthopaedics Ltd). | "Metal-on-metal (MoM) total hip replacements: ADEPT® 12/14 modular head (Finsbury Orthopaedics Ltd). All lots. Higher than expected revision rate for the
ADEPT® 12/14 modular head components when used in a total hip arthroplasty." | 12/03/2013 |
| Select | NICAS-555 | MDA-2013-006 | Infusion pumps. Plum A+ and A+3 family of infusers. Manufactured by Hospira. All models and list num | Infusion pumps. Plum A+ and A+3 family of infusers. Manufactured by Hospira. All models and list numbers. Risk of interruption to treatment. If the pump is running on mains power and the software detects that the battery cannot be fully recharged, an alarm will sound and the infusion will stop. If this occurs the “E321” error message will be displayed. The MHRA continues to investigate this and other recent field safety corrective actions. | 21/02/2013 |
| Select | NICAS-556 | MDA-2013-007 | Isoline implantable cardioverter defibrillator (ICD) leads. All models: 2CR5, 2CR6 and 2CT6. Manufac | "Isoline implantable cardioverter defibrillator (ICD) leads. All models: 2CR5, 2CR6 and 2CT6. Manufactured by Sorin Group Italia Srl. Risk of inappropriate shocking, pacing inhibition or shocking
inhibition due to internal insulation
abrasion." | 21/02/2013 |
| Select | NICAS-552 | EFA-2013-002 | Window restrictors | "Window restrictors.
Window restrictors may be inadequate in preventing a determined effort to force a window open beyond the 100mm restriction." | 23/01/2013 |
| Select | NICAS-550 | EFA-2013-001 | Sharps and sharps containers transported in staff vehicles | "Sharps and sharps containers transported in staff vehicles.
Exposed or inadequately protected sharps left in healthcare staff vehicles put occupants and service personnel at risk of needlestick injury." | 21/01/2013 |
| Select | NICAS-544 | DB2012 - DB2006-06 v2 | DB 2006(06) v2.0 Safe Use of Bed Rails | "We have reviewed and updated this guidance to take into account changes in devices and practices, as well as information gained from the investigation of adverse incidents.
It identifies areas for safe practices, so that policies and procedures can be reviewed and put in place." | 23/11/2012 |
| Select | NICAS-538 | MDA-2012-075 | All medical devices and medicinal products containing chlorhexidine | All medical devices and medicinal products containing chlorhexidine. Risk of anaphylactic reaction due to chlorhexidine allergy. | 25/10/2012 |
| Select | NICAS-527 | DB2012 - DB2006-03 v2 | Blood Pressure Measurement Devices | "The purpose of this document is to provide information and guidance to all involved with the purchase, management and use of non-invasive blood pressure measurement devices. It is a revised edition of the document published in July 2006.
We review the advantages and disadvantages of mercury, aneroid, electronic manual sphygmomanometers and automated blood pressure measuring devices. This should help to ensure the most appropriate technology is selected for use." | 12/09/2012 |
| Select | NICAS-524 | MDA-2012-062 | Silicone tracheostomy tubes | "Silicone tracheostomy tubes
Various manufacturers
Various models
The MHRA is aware of several incidents where the eyelets of tracheostomy tubes appear to have been damaged by the holder. This led to dislodgement of the tube with the subsequent risk of airway loss." | 11/09/2012 |
| Select | NICAS-499 | MDA-2012-038 | Reusable transoesophageal echocardiography - transvaginal and transrectal ultrasound probes | "Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers). All models - All manufacturers.
The MHRA is aware of an incident where the death of a patient from hepatitis B infection may have been associated with a failure to appropriately decontaminate a transoesophageal echocardiography probe between each patient use.
The MHRA is issuing this alert to advise users to appropriately decontaminate all types of reusable ultrasound probes." | 02/07/2012 |
| Select | NICAS-498 | MDA-2012-036 | All metal-on-metal (MoM) hip replacements | All metal-on-metal (MoM) hip replacements. The MHRA is issuing updated information and advice about the follow-up of patients implanted with metal-on-metal (MoM) hip replacements. | 25/06/2012 |
| Select | NICAS-484 | MDA-2012-022 | Dermal filler for breast augmentation.Macrolane™ Volume Restoration Factor (VRF). | "Dermal filler for breast augmentation.
Macrolane™ Volume Restoration Factor (VRF). Manufactured by Q-Med AB (a Galderma division).Manufactured by Q-Med AB (a Galderma division). Use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation can make diagnosis of breast cancer more difficult, particularly with the use of mammography." | 25/04/2012 |
| Select | NICAS-482 | MDA-2012-020 | Oral swabs with a foam head | "Oral swabs with a foam head.
Foam heads of oral swabs may detach from the stick during use. This may present a choking hazard for patients." | 13/04/2012 |
| Select | NICAS-476 | EFA-2012-002 | Equipment using ultraviolet (UV) tubes. | "Equipment using ultraviolet (UV) tubes. Ultraviolet light tubes (UVA, UVB and UVC)
are interchangeable and the wrong type
can be fitted to equipment. Risks include radiation burns and loss of effectiveness." | 29/03/2012 |
| Select | NICAS-472 | MDA-2012-011 | Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All implanted devi | Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All implanted devices. In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010. | 15/03/2012 |
| Select | NICAS-466 | MDA-2012-005 | Stapler - Duet TRS universal straight and articulating single use loading units (SULU) - Manufacture | "Stapler - Duet TRS universal straight and articulating single use loading units (SULU) - Manufactured by Covidien.
Covidien has issued advice following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.
These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening post-operative complications." | 16/02/2012 |
| Select | NICAS-461 | EFA-2012-001 | Integral side-stay mechanism window restrictors fitted with plastic spacers | "Integral side-stay mechanism window restrictors fitted with plastic spacers.
Certain types of side-stay window restrictors incorporate a plastic spacer which, if allowed to deteriorate and crack, may result in separation of the retaining rivet and failure of the restrictor.
Even with a restrictor fitted to each side of the window, the failure of one restrictor may be enough to allow egress with high risk of injury or death." | 17/01/2012 |
| Select | NICAS-456 | NIA-2011-003 | Electrically operated office equipment inappropriately located in a primary fire escape route | "Electrically operated office equipment inappropriately located in a primary fire escape route.
The equipment was misused which caused it to overheat, resulting in large amounts of smoke being generated. This caused a fire evacuation route to become unusable during the partial evacuation of a patient area." | 19/12/2011 |
| Select | NICAS-450 | MDA-2011-108 | Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO). All Aestiva, Aisys, Aespire and Advance ana | "Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO). All Aestiva, Aisys, Aespire and Advance anaesthetic machines.
Manufactured by GE Healthcare. The accidental, incorrect setting of the ACGO
switch will result in no fresh gas flow to the
patient. Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in patient barotrauma." | 01/12/2011 |
| Select | NICAS-436 | MDA-2011-097 | Implantable pacemakers manufactured by Medtronic. EnRhythm®: Model P1501DR is a dual chamber rate re | "Implantable pacemakers manufactured by Medtronic. EnRhythm®: Model P1501DR is a dual chamber rate responsive pacemaker. EnRhythm MRI™ SureScan:Model EMDR01 IPG is a modified EnRhythm® P1501DR which is MR Conditional. Following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in
some EnRhythm® and EnRhythm MRI™
devices." | 28/09/2011 |
| Select | NICAS-432 | NIA-2011-002 | Flexible water supply hoses | "Flexible water supply hoses.
Risk of harmful micro-organisms
When used for the supply of potable water, some flexible hoses may have an enhanced risk of harbouring Legionella bacteria and other potentially harmful microorganisms" | 23/08/2011 |
| Select | NICAS-405 | MDA-2011-068 | Needle-free intravenous connectors. All manufacturers. All models. | Needle-free intravenous connectors. All manufacturers. All models. Incompatibility of some pre-filled glass syringes with various needle-free connectors. Possible risk of infection and/or air embolus to patients when an adaptor remains attached to a needle-free connector after use. | 15/06/2011 |
| Select | NICAS-403 | MDA-2011-066 | All Plum A+ infusion pumps - Manufactured by Hospira Inc | "All Plum A+ infusion pumps - Manufactured by Hospira Inc.
Risk of delay or interruption to treatment.
The audible alarm on all listed Plum A+ infusion pumps may fail.
The visual alarm is not affected. However, if the user does not notice the visual alarm they may be unaware of an interruption to the infusion e.g. air-in-line or occlusion." | 09/06/2011 |
| Select | NICAS-388 | MDA-2011-051 | Implantable cardioverter defibrillator (ICD) lead manufactured by Medtronic | "Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis, model numbers: 6930, 6931, 6948 and 6949 Manufactured by Medtronic.
Risk of inappropriate shocks and loss of therapy.
Increased risk that the high voltage conductor will fracture if the pace-sense conductor has previously fractured in the same lead." | 19/05/2011 |
| Select | NICAS-363 | MDA-2011-026 | Ligasure blunt tip laparoscopic sealer/divider. | "Ligasure blunt tip laparoscopic sealer/divider. Manufactured by Covidien.
Catalogue number: LF1537. Specific lot numbers. During diathermy (electrosurgery) procedures the device may spontaneously energize when
clamping, without the activation button being pushed. Although no injuries have been reported, this could cause an unintended energy delivery to
tissue resulting in serious thermal burns." | 15/03/2011 |
| Select | NICAS-339 | NIA-2011-001 | Estates Systems, Plant and Buildings | "Estates Systems, Plant and Buildings.
Reporting estates related adverse incidents to the Northern Ireland Adverse Incident Centre (NIAIC)." | 12/01/2011 |
| Select | NICAS-322 | DB2010RevDB2003-02 | Infusion Systems | "The Medicines and Healthcare products Regulatory Agency (MHRA) receives many reports of incidents involving infusion pumps. These incidents are of concern as many result in patient harm or death, primarily from over-infusions.
This publication has been updated to take into account changes in devices and practices, as well as information gained from the investigation of adverse incidents and current trends in the use of infusion systems." | 18/11/2010 |
| Select | NICAS-313 | EFA-2010-010 | Automated thermal washer disinfectors with independent monitoring | "Automated thermal washer disinfectors with independent monitoring.
There is a risk of infection if surgical instruments are processed in a faulty or incorrectly set up automated thermal washer disinfector with inadequate or disabled independent monitoring." | 19/10/2010 |
| Select | NICAS-308 | MDA-2010-078 | Silicone gel filled breast implants manufactured by Poly Implant Prothese - All devices implanted af | "Silicone gel filled breast implants manufactured by Poly Implant Prothese - All devices implanted after 01 January 2001.
Clinical management of women implanted with PIP silicone gel filled implants." | 04/10/2010 |
| Select | NICAS-303 | MDA-2010-073 | Intravenous (IV) extension sets with multiple ports: all brands. | Intravenous (IV) extension sets with multiple ports: all brands. Risk of back-tracking when an IV line has multiple access ports. This can lead to under-infusion or bolus delivery of IV drugs. | 20/09/2010 |
| Select | NICAS-294 | MDA-2010-064 | Novabel® dermal filler. Manufactured by Merz Pharmaceuticals GmbH. 1x1 ml, Art.-Nr. 40800 and 2x1ml, | Novabel® dermal filler. Manufactured by Merz Pharmaceuticals GmbH.1x1 ml, Art.-Nr. 40800 and 2x1ml, Art.-Nr. 49021. All batches. Use of Novabel® dermal filler may cause adverse reactions. | 12/08/2010 |
| Select | NICAS-291 | EFA-2010-008 | Unsecured medical gas cylinders, including cylinders on trolleys | "Unsecured medical gas cylinders, including cylinders on trolleys.
Medical gas cylinders which are not secured properly can topple causing injury or death. This includes cylinders which may be free standing and those held in cylinder trolleys." | 27/07/2010 |
| Select | NICAS-288 | EFA-2010-007 | Window blinds with looped cords or chains. All types. | "Window blinds with looped cords or chains. All types.
Looped cords and chains on window blinds can present a strangulation hazard to children and vulnerable adults.
There have been a number of deaths associated with these types of blind cords throughout the UK." | 08/07/2010 |
| Select | NICAS-282 | MDA-2010-054 | Fetal monitor-cardiotocograph (CTG). | "Fetal monitor/cardiotocograph (CTG).
This replaces MDA SN 2002(23) issued August 2002 and Northern Ireland - SN (NI)2002/28 issued 27 August 2002.
Adverse outcomes are still being reported in the presence of CTG traces that appear normal. For example, the display of double maternal heart rate (MHR x 2) can be falsely reassuring." | 28/06/2010 |
| Select | NICAS-272 | NIA-2010-001 | Convector heaters, Micromark | Convector heaters, Micromark - Risk of fire. At least five incidents involving these heaters have been reported. | 02/06/2010 |
| Select | NICAS-265 | MDA-2010-039 | All Aquarius haemofiltration machines. Manufactured by Edwards Lifesciences Ltd and | "All Aquarius haemofiltration machines. Manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare. Reports have been received of the wheels
breaking due to wear or improper use. There is a risk of the machine toppling or falling over,which can cause injury and therapy interruption." | 12/05/2010 |
| Select | NICAS-262 | MDA-2010-036 | All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators. | "All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators.
The MHRA continues to receive reports of inadequate patient ventilation and oxygenation where harm could have been avoided if an alternative means of ventilation had been used earlier. These incidents occurred because of misconnection, entrapment or occlusion of the anaesthetic breathing systems, or because the anaesthetic machine or ventilator had failed.
In one particular incident an anaesthetic breathing system was wrongly connected to the auxiliary common gas outlet of an anaesthetic machine. The effects of this were wrongly interpreted as bronchospasm and the usual drug regimens were administered. The time taken to finally identify that this was a problem with the equipment meant that the patient was harmed.
Whilst such equipment issues are uncommon, they should be considered as a matter of course when problems with patient ventilation occur." | 06/05/2010 |
| Select | NICAS-248 | MDA-2010-025 | Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All models and lot | "On Tuesday 30 March 2010 the French medical device regulatory authority (AFSSAPS) informed the MHRA that it has suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). It has recalled all of these devices. AFSSAPS recently carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved.
The MHRA does not yet know if the use of the unapproved material affects the safety of the implants. We understand that AFSSAPS is carrying out urgent testing and has undertaken to provide further information as soon as it is available.
The MHRA will provide further advice on patient management, as necessary, when more information is available." | 31/03/2010 |
| Select | NICAS-244 | EFA-2010-002 | Access Hatches | Access Hatches - A patient has managed to remove an unsecured loft access hatch in a ward area enabling access to services in the void above, attach a ligature, and commit suicide. | 16/03/2010 |
| Select | NICAS-240 | MDA-2010-020 | Hansen type coloured connectors on dialysis fluid lines used on Dialysis and Haemodiafiltration mach | "Hansen type coloured connectors on dialysis fluid lines used on Dialysis and Haemodiafiltration machines.
All manufacturers.
Potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) resulting in a significantly less efficient dialysis." | 10/03/2010 |
| Select | NICAS-230 | DB2010(NI)-01 | Reporting Adverse Incidents and Disseminating Medical Device Alerts | "Reporting Adverse Incidents and Disseminating Medical Device Alerts.
This publication provides guidance on the NIAICs voluntary adverse incident reporting system and encourages users to report adverse incidents involving medical devices." | 10/02/2010 |
| Select | NICAS-231 | DB2010-02 | Management and use of IVD point of care test devices | "Management and use of IVD point of care test devices.
The aim of this document is to provide advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. It is a revised edition of the version first published in 2002 as DB 2002(03)." | 10/02/2010 |
| Select | NICAS-226 | MDA-2010-008 | Intraocular lens (IOL) – hydrophilic acrylic. | Intraocular lens (IOL) – hydrophilic acrylic. Opacification of IOLs may occur following intracameral use of alteplase (recombinant tissue plasminogen activator, r-tPA). | 21/01/2010 |
| Select | NICAS-224 | MDA-2010-006 | Devices used for endometrial ablation - All makes and models. | "Devices used for endometrial ablation - All makes and models.
The MHRA continues to receive reports of uterine wall injury, wall perforation, or the creation of a false passage following use of endometrial ablation devices. In some cases resection of damaged tissue has been required.
The majority of complications occur due to either poor patient selection or endometrial ablation procedures being performed in difficult situations.
Patients with either a retroverted uterus or a fixed uterus (e.g. due to significant endometriosis or adhesions), or those that have had previous uterine surgery are at a higher risk." | 18/01/2010 |
| Select | NICAS-222 | EFA-2010-001 | UK-wide Estates & Facilities Alert (EFA): | "UK-wide Estates & Facilities Alert (EFA):
A change to the format of the safety warning Alerts published by the Northern Ireland Adverse Incident Centre (NIAIC)." | 12/01/2010 |
| Select | NICAS-219 | MDA-2010-002 | All types of bed mattresses. | "All types of bed mattresses - If mattress covers are damaged, body or other
fluids can pass through and contaminate the inner core. There is the potential for cross-infection if contaminated mattresses remain in use." | 05/01/2010 |
| Select | NICAS-211 | MDA-2009-080 | Ultrasound transducer probes with an internal lumen used for taking transrectal prostate biopsies. | "Ultrasound transducer probes with an internal lumen used for taking transrectal prostate biopsies. Potential onward transmission of abnormal prion protein, the putative infective agent in variant Creutzfeldt Jakob disease (vCJD), when ultrasound transducer probes with an internal lumen are used for taking transrectal prostate biopsies on men at risk of vCJD. The needle that passes through the internal lumen of a reusable ultrasound probe could transfer the abnormal prion protein from rectal lymphoid tissue, via the outside surface of the biopsy needle, onto the internal lumen of the ultrasound probe. Any attempt at subsequent decontamination of the internal lumen would not be successful due to the inability of any current decontamination process to reliably eliminate or destroy abnormal prion protein.
The needle that passes through the internal lumen of a reusable ultrasound probe could transfer the abnormal prion protein from rectal lymphoid tissue, via the outside surface of the biopsy needle, onto the internal lumen of the ultrasound probe. Any attempt at subsequent decontamination of the internal lumen would not be successful due to the inability of any current decontamination process to reliably eliminate or destroy abnormal prion protein." | 09/12/2009 |
| Select | NICAS-207 | MDA-2009-076 | Aquarius haemofiltration machine - Manufactured by Edwards Lifesciences Ltd. | "Aquarius haemofiltration machine - Manufactured by Edwards Lifesciences Ltd.
This Alert provides an update on actions taken by Edwards Lifesciences, as advised in MDA/2009/012." | 25/11/2009 |
| Select | NICAS-162 | MDA-2009-032 | Bioprosthetic heart valves - All makes and models. | "Bioprosthetic heart valves - All makes and models.
Early valve revision with associated morbidity or mortality risks if these valves are not adequately washed or rinsed prior to implantation.
Residues of chemicals typically used in the storage of bioprosthetic heart valves can adversely affect the patient’s annular tissue and lead to premature failure of the valve." | 29/04/2009 |
| Select | NICAS-159 | MDEA(NI)2009-003 | ASDA ‘Durabrand’ domestic microwave oven XB2316: | ASDA ‘Durabrand’ domestic microwave oven XB2316: recall due to risk of fire - A manufacturing fault on ASDA ‘Durabrand’ domestic microwave ovens (model XB2316) has resulted in a risk of overheating and fire. The supplier issued a product recall notice in February 2008. | 27/04/2009 |
| Select | NICAS-155 | MDEA(NI)2009-002 | Operating Theatre Lamps | Operating Theatre Lamps - Operating theatre lamps should continue to function on battery if the normal electrical supply fails. Consideration should also be given to battery back-up in case the operating lamp control unit fails. | 16/04/2009 |
| Select | NICAS-148 | MDEA(NI)2009-001 | GEMU steam valve actuator model : CN 33548 Manufacturer No : 1993208 (manufactured prior to 12th Jul | "GEMU steam valve actuator model : CN 33548 Manufacturer No : 1993208 (manufactured prior to 12th July 2004) - Escape of steam under pressure with the potential to cause injury.
A steam valve actuator supplying steam to an autoclave (sterilizer) failed allowing steam to escape under pressure into the atmosphere." | 26/03/2009 |
| Select | NICAS-126 | MDA-2008-087 | Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed | Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 - Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning. | 18/12/2008 |
| Select | NICAS-112 | MDA-2008-068 | Implantable cardioverter defibrillators (ICDs) - disable all high voltage shock therapies before you | (All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). | 22/10/2008 |
| Select | NICAS-104 | DB2008(04) | In Vitro Diagnostic Medical Devices Used in Combination | In vitro diagnostic medical devices (IVDs) are often used in combination with other devices and equipment. Combining IVDs with other devices and equipment needs to be carefully planned and managed so that the combination does not impair the performance of any of the individual devices. | 24/09/2008 |
| Select | NICAS-103 | DB2008(03) | Guidance on the safe use of lasers, intense light source systems and LEDs in medical, surgical, dent | This guidance document relates to medical lasers and other types of optical radiation devices, including light emitting diodes (LEDs) and intense light/heat sources, referred to as intense pulsed light (IPL) (sources) systems in the text. Equipment used in conjunction with the optical radiation equipment, such as optical fibres, contact tips, articulated arms etc. are also reviewed. | 24/09/2008 |
| Select | NICAS-80 | MDA-2008-046 | Lancing devices (used in pharmacy settings) – all brands. (Formly MDEA(NI)2008-50) | Lancing devices (used in pharmacy settings) – all brands. Risk of transmission of blood borne infections between patients if a lancing device is used for multiple patient testing, contrary to the manufacturer's instructions for use. | 03/07/2008 |
| Select | NICAS-70 | MDA-2008-038 | Implantable drug pumps for intrathecal therapy - risk of temporary or permanent neurological impairm | (All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. | 09/06/2008 |
| Select | NICAS-71 | MDEA(NI)2008-041 | All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs. | All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs - Use of an inappropriate type of, or incorrectly fitted or adjusted posture/safety belt can lead to death or serious injury of the occupant. | 09/06/2008 |
| Select | NICAS-67 | DB2008(NI)02 | ADVERSE INCIDENT REPORTS 2007 | ADVERSE INCIDENT REPORTS 2007 | 30/05/2008 |
| Select | NICAS-60 | DB2008(NI)01 | Reporting adverse incidents and disseminating medical device alerts | Reporting adverse incidents and disseminating medical device alerts. | 01/05/2008 |
| Select | NICAS-26 | MDA-2007-078 | (Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around | Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture | 19/10/2007 |
| Select | NICAS-24 | MDA-2007-042 | External pacemakers and temporary cardiac pacing leads - concerns that insecure systems still being | (All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers. | 23/05/2007 |
| Select | NICAS-21 | MDA-2007-031 | Patient hoists and slings - ensure you follow manufacturer's instructions for use and that you carry | (All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. | 23/04/2007 |
| Select | NICAS-15 | MDA-2006-022 | MiniCap peritoneal dialysis disconnect cap with povidone-iodine - monitor thyroid function in patien | (Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. | 22/03/2006 |
| Select | NICAS-14 | MDA-2006-019 | All cochlear implants - update on immunisation recommendations | (All) risk of pneumococcal meningitis in cochlear implant patients. | 16/03/2006 |
| Select | NICAS-10 | MDA-2005-045 | Implantable cardioverter defibrillators (ICDs) - ensure you have updated software for models 3510 an | (St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. | 25/07/2005 |
| Select | NICAS-7 | MDA-2004-047 | Trilucent (soya bean oil filled) breast implants - update on actions from previous risks | (Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05). | 25/09/2004 |
| Select | NICAS-3 | MDA-2003-037 | Electrosurgical (diathermy) accessories - ensure procedures are in place to check all electrosurgica | (All) malfunction and failure during use. | 27/10/2003 |
| Select | NICAS-2 | MDA-2003-035 | SynchroMed® implantable drug pump - consider changing diamorphine for another medicine | (Medtronic) diamorphine solution is incompatible with the implantable drug pump. | 22/10/2003 |