Field Safety Notices (FSNs): 02/12/24 – 06/12/24

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General List

Outlook tags     IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)

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

1.     Product Recall: Flogas Gold Butane Gas Cylinder (2411-0181)

Section 2: medical devices 02/12/24 – 06/12/24

1. Abbott: MERLIN PATIENT CARE SYSTEM 45597 Application Software Model: 3650 MHRA reference: 34004831   2024/011/021/601/030
2. Accuray: Cyberknife 22nd November 2024 MHRA reference: 34125618    2024/012/004/601/067
3. Becton Dickinson: Refer to FSN 45624 Model: Refer to FSN MHRA reference: 34086177 
4. Change Healthcare Canada Company: MC Hemo, CHC Hemo, CHC Hemodynamics 45627 Cardiac Catheterization laboratory computer Model: Refer to FSN MHRA reference: 34085791   2024/012/001/601/003
5. ELITech Group: ELITe InGenius Consumable Set 14th November 2024 Thermal cycler nucleic acid amplification analyser MHRA reference: 34112764   2024/012/003/601/017
6. Harrogate Healthcare: White cross podiatry standard pack 12th September 2024 MHRA reference: 34102228   2024/009/025/601/063
7. Medtronic: UNID ROD 45627 Bone-screw internal spinal fixation system rod MHRA reference: 34114078   2024/012/003/601/135
8. Medtronic: Sterile Percutaneous Reference Pin 45627 Orthopaedic stereotactic surgery system Model: 9733235, 9733236 MHRA reference: 34130010   2024/012/004/601/116
9. Werfen : ROTEM sigma complete / ROTEM sigma complete + hep 25th November 2024 Multiple coagulation factor IVD, kit, clotting MHRA reference: 34113264   2024/012/003/601/067 MHRA reference: 34113264   2024/012/003/601/067 – Customer reply form

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

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/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

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 in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

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