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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 31 July to 04 August 2023
- Abbott: Trifecta Valve, Trifecta Valve w. Glide Technology 45138 Aortic Heart Valve Bioprosthesis Model: TF-19A, TF-21A, TF23A, TF25A, TF-27A, TF-29A, TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A MHRA reference: 5437718
- Abbott: HeartMate Touch Communication System 45139 Multiple active implantable device programmer Model: HMT1150 MHRA reference: 5442038
- bioMérieux: EBV R-GENE (Ref. 69-002B) – BK Virus R-GENE (Ref. 69-013B) 45139 MHRA reference: 5437365
- Canon: Vantage Galan,Vantage Centurian,Vantage Titan 45134 Full-body MRI system, superconducting magnet Model: MRT-3010, MRT-3020 MHRA reference: 5437298
- Getinge: APERLAN PY AGENT A, APERLAN PY AGENT B 45142 Disinfectant, medical device Model: APERLAN PY AGENT A, APERLAN PY AGENT B MHRA reference: 6924181
- ICU Medical: Volumetric infusion pump & infusion sets 45140 MHRA reference: 5437735
- LINK: MobileLink Acetabular Cup System 45121 Acetabular shell Model: 183-610/05 MHRA reference: 5395267
- Medtronic: Activa Clinician Programmer Application 45139 Multiple active implantable device programmer Model: A610 MHRA reference: 5442065
- Siemens Healthineers: Symbia Pro.specta CAN 001-2023 SPECT/CT Diagnostic Imaging System Model: 11364752, 11364753 MHRA reference: 5457782
- Teleflex: Endotracheal Tubes 45047 Basic endotracheal tube, single-use MHRA reference: 5437203
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
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts
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
FAC406-015, 8B(i), Rev 6
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