Field Safety Notices (FSNs): 28/10/24 – 01/11/24

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: 3M™ PELTOR™ X4 Series Earmuffs (2404-0090)  Published by OPSS on 27^th July 2024.

Section 2: medical devices 28/10/24 – 01/11/24 (please note FSNs 1 & 2 are in separate page dated 30/10/24)

1. Abbott: Hamilton Medical : HAMILTON-C6 45593 Neonatal/adult intensive-care ventilator Model: 160021 MHRA reference: 33749925 2024/010/029/601/108
2. BD: 4Fr Single-Lumen PowerPICC Catheters 45595 Peripherally-inserted central venous catheter MHRA reference: 33739247 2024/010/028/601/056
3. Abiomed: Impella heart pump 45384 Intracardiac Circulatory Assist Axial Pump Cath. Model: all models of Impella heart pumps MHRA reference: 33776034   2024/002/025/601/001
4. Arjo: IndiGo Intuitive Drive Assistance 45536 Accessory for basic electric hospital beds Model: INDI-XXX MHRA reference: 33615874     2023/012/013/601/033
5. Becton, Dickinson and Company: See comments box 45602 See comments box MHRA reference: 33783989     2024/010/031/601/058 
6. Bordier Affinity Products: As described in the FSN-240829UK – Attached 45533 MHRA reference: 33744394   2024/010/028/601/045
7. Dutch Ophthalmic Research Center (DORC): Silicone Oil 45536 Vitreous humour replacement medium, intraoperative MHRA reference: 33772908   2024/010/015/601/033
8. Getinge: Universal Remote Control 45586 Medical device remote control keypad Model: 100925A0 MHRA reference: 33723020    2024/010/025/601/079 – Customer letter MHRA reference: 33723020    2024/010/025/601/079 – Reply form 
9. HYALTECH: Visthesia 1.5% 45575 Ophthalmic Viscosurgical Devices MHRA reference: 33728193    2024/010/024/601/003
10. SIEMENS Healthineers: Atellica CH ß2-Microglobulin (B2M) 45566 See section 8 MHRA reference: 33768573   2024/010/029/601/126
11. Smiths Medical: Tracheal Tube Reusable Introducer and Guides 45600 Endotracheal tube introducer/guide, reusable Model: See FSN MHRA reference: 33768404    2024/010/030/601/028
12. TAEWOONG Medical : Niti-S Tracheobronchial Uncovered Stent 45365 Bare-metal tracheal/bronchial stent, sterile Model: BRxxxxW MHRA reference: 33728108   2024/003/014/601/001

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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