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This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.
This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.
You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.
Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).
Section 1: estates, facilities or general products
- None
Section 2: medical devices 20/05/24 – 24/05/24
- Abbott: 2nd Generation CentriMag Primary Console 45413 Cardiopulmonary bypass system centrifugal pump Model: 201-30300, 201-90401, 201-90701, L201-90401, L201-90421 MHRA reference: 30564240
- Cadwell: Cascade IOMAX Cortical Module 45429 Model: 19029603AA0224009, 19029603AA0324006, 19029603AA0424009 MHRA reference: 30478281
- CooperSurgical: global Medium 45413 IVF medium MHRA reference: 30570643
- Fresenius: multiFiltratePRO 45425 Haemodialysis system, institutional/home-use Model: M205001 MHRA reference: 30556885
- ICU Medical: Plum 360, Plum A+ & Plum A+3 infusion systems 45439 Bedside infusion pump, single-channel MHRA reference: 30565503
- Integra: Cusa Excel 23kHz Straight Handpiece 45436 Soft-tissue ultrasonic surgical system handpiece MHRA reference: 30679861
- Invivoscribe: LymphoTrackDx – MiSeq 45428 Model: 92270009 – LymphoTrack Dx TRG Assay Panel – MiSeq, 91210059 – LymphoTrack Dx IGHV SHM Kit A – MiSeq, 91210069 – LymphoTrack Dx IGHV SHM Assay Panel – MiSeq MHRA reference: 30482646
- LINK: Endo-Model-M & Endo-Model SL (Tibial components) 45434 Rotating hinged total knee prosthesis Model: 15-2814/01 MHRA reference: 30569352
- Masimo: RAd-G Pulse Oximeter 45411 Pulse oximeter MHRA reference: 30453101
- QuidelOrtho: VITROS Immunodiagnostic Products Anti-HBs Cal 45426 Hepatitis B virus surface total antibody IVD, kit MHRA reference: 30556878
- Stryker: Hoffmann LRF Wire Tensioner 45413 Orthopaedic external fixation system, single-use MHRA reference: 30564115
- Stryker: Mako Total Knee May 2024 RA2024-3598242 MHRA reference: 30565709
- Thermo Fisher: YERSINIA AGAR (CIN MED) 45432 MHRA reference: 30568861
The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here.
Section 3: updates and changes to previously published medical device FSNs
Page summary | Change(s) made |
None | n/a |
Adverse Incidents
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
- Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
- Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
- Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Incident Reporting & Investigation Centre (IRIC)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more about our services at www.nss.nhs.scot
FAC406-212, 8B(i), Rev 7
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