Field Safety Notices (FSNs): 14/10/24 – 18/10/24

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: ROCKRIDER Helmet MTB EXPL500 or ST500 sold by Decathlon (2409-0129)

2.    Product Safety Report: LPG-Powered Lift Trucks

3.    Product Recall: Avionaut Dock 2 Isofix Children’s Car Seat Base (2409-0153)

Section 2: medical devices 14/10/24 – 18/10/24

1. Integra Lifesciences: Codman® Surgical Patties & Surgical Strips 45558 Neuro surgical sponge Model: Refer to FSN MHRA reference: 32969037   2024/009/025/601/068
2. Ultragel Medical Kft: Ebrington Medical AquaUltra clear Ultrasound Gel 45582 Topical skin coupling gel for use in ultrasound scanning procedures Lot No: 2024.04 MHRA reference: 32981526

3. Advanced Medical Solutions Ltd: Wound care dressings 45576 Model: Refer to FSN MHRA reference: 32933608   2024/010/001/601/111
4. Baxter Medical Systems: TruSystem 7000 Surgical Table 45575 Universal operating table, electromechanical Product Code: 1604786, 1604788, 1723633, 1841046, 1841048, 1841049, 1841050, 1841082, 1841083, 2065385, 2065386 Serial Numbers: All MHRA reference: 32895251 – Letter   2024/010/009/601/046 MHRA reference: 32895251 – Health care provider
5. Beckman Coulter: Access TSH (3rd IS) 2×200 DET 45533 Reagent Packs Model: C28643, LOT number: 339117, 338724, 439341, 338367, 338057, 234251 MHRA reference: 31739277   2024/008/030/601/019 MHRA reference: 31739277 – Vigilance response form
6. Biotype: Mentype® AMLplexQS PCR Amplification Kit 45562 In-vitro-Diagnostic Medical Device (IVDD) Model: Refer to FSN MHRA reference: 32904688   2024/010/011/601/026 MHRA reference: 32904688 – Instructions for Use
7. Boston Scientific Ltd: POLARx & POLARx FIT Cryoablation Balloon Catheters 45575 Cardiac Cryosurgical System Catheter Model: Refer to FSN MHRA reference: 32895054   2024/010/010/601/081
8. Cook Medical: Approach® CTO Micro Wire Guides, Approach® Hydro ST Micro Wire Guides 45567 Peripheral vascular guidewire, manual Model: Refer to Attachment 1 – Product Information Table MHRA reference: 32926469   – FSN MHRA reference: 32926469   – Attachment 1. Product Information MHRA reference: 32926469   – Customer reply form MHRA reference: 32926469   – Distributor/Importer reply form
9. FujiFilm: Synapse PACS Software 45546 Radiological PACS software Software version: 7.1.x, 7.2.x, 7.3.0.x MHRA reference: 31814714   2024/009/006/601/046
10. Medtronic Limited: MiniMedTM 600 series and 700 series pump systems 45566 Micro infusion pumps Model: Refer to FSN MHRA reference: 32961348 – Health care professional  2024/010/016/601/032 MHRA reference: 32961348 – Distributor letter MHRA reference: 32961348 – Diabetes Community member
11. Permobil/Panthera AB: Carbon fiber side guards with untrimmed edge Side Guards Model: Refer to FSN MHRA reference: 32924390   2024/010/007/601/054
12. Unimax Medical Systems: Detachable EndoRetrieval Pouch 45553 Tissue extraction bag Model: SB936; SB979 MHRA reference: 32971191  MHRA reference: 32971191 – 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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