Field Safety Notices (FSNs): 09/12/24 – 13/12/24

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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 Safety Report: MK Electric MK Essentials Electrical Three Pin Sockets with Switches (2411-0130)

….

Section 2: medical devices 09/12/24-13/12/24

1. Altomed: Iris retractors 45629 Intraocular Retractor, Single Use Model: A2271, A2273 MHRA reference: 34154761   2024/012/005/601/078
2. Baxter Medical Systems: TruSystem 7000 Surgical Table – UPDATE 45625 Universal operating table, electromechanical Product Code: Refer to FSN MHRA reference: 34156100   2024/010/009/601/046
3. Biocartis: Idylla™ Instrument 45635 Model: Refer to FSN MHRA reference: 34165566   2024/012/008/601/001
4. Coloplast: see details in Appendix 1 version 3.0 45631 Model: Refer to FSN MHRA reference: 34154704   2024/012/005/601/096
5. GE HealthCare: Carestation 620/650/650c Ref. # 34140 Anaesthesia workstation, general-purpose Model: Refer to FSN MHRA reference: 34169134   2024/012/009/601/017
6. GE HealthCare: EC Elite, OEC 3D, OEC 9900, OEC 9800 Ref. #15150 X-ray system, diagnostic, fluroscopic, general Model: Refer to FSN MHRA reference: 34154729   2024/012/006/601/051
7. GE HealthCare: Optima XR200amx, Optima XR220amx and Optima XR240amx Ref. # 10964 X-ray system, diagnostic, General-Purpose, Mobile MHRA reference: 34176852   2024/012/010/601/088
8. HMT Medizintechnik GmbH: Refer to FSN 45635 Vacuum-tight reservoir Model: Refer to FSN MHRA reference: 34176818   2024/012/010/601/094
9. Medtronic: Arterial Cannulae 45627 Model: Refer to FSN MHRA reference: 34192884   2024/012/011/601/059
10. Medtronic: SynchroMed™ A810 Clinician Programmer Software Application v2.x. 45597 Implantable Pumps Programmers – MD software Model: A810 MHRA reference: 34176085   2024/012/010/601/067
11. Richard Wolf: PIEZOWAVE 2 CONTROL UNIT, LITHOTRIPTOR 3000PLUS, SWISS PIEZOCLAST 45630 Model: Refer to FSN MHRA reference: 34155106 – FSN  2024/012/007/601/003 MHRA reference: 34155106 – Response form
12. Terumo-Vascutek: Thoraflex Hybrid 45575 Model: Refer to FSN MHRA reference: 34165983   2024/010/014/601/029

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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