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Manufacturers’ Field Safety Notices
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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 27/03/23 – 31/03/23
- ams: Infusion Sets 44971 Model: A22BL-Set MHRA reference: 5079933
- Cook Medical: AdvanceMicro 14UltraLow-ProfilePTA Balloon Catheter 44986 Peripheral angioplasty balloon catheter MHRA reference: 5093604
- Genetic Signatures: EasyScreen Sample Processing Kit 45006 MHRA reference: 5134296
- ICU Medical: Plum 360 infusion system 45019 MHRA reference: 5139815
- Leica Biosystems: Novocastra Muscle Specific Actin 44897 MHRA reference: 5132941
- Linvatec (Conmed): I.B.S®-C Compression screws 45007 Orthopaedic bone screw, non-bioabsorbable, sterile Model: S30 ST128 ; S25 ST024 ; S25 ST026 MHRA reference: 5132721
- Medi Plinth: Essential 2/3 Section Plinths 44972 MHRA reference: 5132463
- MOBIDIAG: Novodiag CarbaR+ 44957 Multiple-type gastrointestinal pathogen nucleic ac Model: V2 MHRA reference: 5133983
- Ortho Solutions: K-WIRE TROCAR TIP 1.0MM X 70MM 45014 Model: OS292100H MHRA reference: 5139819
- Philips: Spectral CT 7500 45002 Full-body CT system Model: 728333 MHRA reference: 5133756
- Philips: Ingenia Elition, MR 7700 44946 Magnetic Resonance Imaging (MRI) unit Model: 781358, 782107, 782119, 782136, 781357, 782106, 782137, 782118, 782132, 782144, 782120, 782130 MHRA reference: 5139821
- Philips: Incisive CT 45005 Full-body CT system Model: 728143,728144 MHRA reference: 5132783
- Poly Medicure: Polyflush Syringe Single Sterile 45006 MHRA reference: 5133743
- Siemens Healthineers: Artis one AX061-22-2 March 2023 Stationary angiographic x-ray system, digital Model: 10848600 MHRA reference: 5130054
- Siemens Healthineers: Atellica IM Cortisol, ADVIA Centaur Cortisol 44986 MHRA reference: 5132458
- Sylk: SYLK Intimate 44994 MHRA reference: 5114080
- Sysmex: Revohem ADP 45009 Platelet aggregation study IVD, reagent MHRA reference: 5132449
- Tridentify: QTA Tracer 2.0 44994 Medical product temperature point indicator, elect MHRA reference: 5132511
- werfen: HemosIL Liquid Anti-Xa 45000 Heparin Anti-xa MHRA reference: 5122348
- Zimmer Biomet: Oxford Fixed Lateral 44924 Unicondylar knee prosthesis Model: 154341 MHRA reference: 5142306
- ….
- ….
- ….
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.
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)
Health Facilities Scotland
NHS National Services Scotland
Contact us:
IRIC Email nss.iric@nhs.scot
Helpline 0131 275 7575
Web https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts
Please consider the environment before printing this email.
NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org
FAC406-015, 8B(i), Rev 6
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