Field Safety Notices (FSNs): 23/12/24 – 27/12/24

Manufacturers’ Field Safety Notices

Circulation

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: Auchan Baby Soothers (2412-0104)

2.     Product Recall: 3M DBI-SALA Sealed-Blok Self-Retracting Lifeline (2412-0126)

Section 2: medical devices 23/12/24 – 27/12/24

1. Braun: HAEMOSTATIC FORCEPS / CLAMPS 20th December 2024 Surgical soft-tissue manipulation forceps, s Model: BH100RBH104RBH105RBH108RBH109 MHRA reference: 34289629    2024/012/023/601/013
2. Fresenius Medical Care: 4008H, B, S, Art, Prometheus 19th December 2024 Haemodialysis system, institutional/home-use Model: M20068(1) 4008H M20011(1) 4008B M20066(1) 4008 S Standard M20067(1) 4008 S (Standard + CDS) M20084(1) 4008 S (Standard + ONLINEplus) M20085(1) 4008S (Standard + CDS + ONLINEplus) 9798931 Art Standard 9798941 Art Universal M201231 Prometheus Standard Hepa M201241 Prometheus Standard CiCa MHRA reference: 34307765    2024/012/024/601/024
3. Mercury Medical: Neo-Tee T-Piece Resuscitator 5th December 2024 MHRA reference: 34319531   2024/012/018/601/033 
4. Philips: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 21st November 2024 Portable Electric Ventilator MHRA reference: 34292213    2024/009/020/601/069
5. QuidelOrtho: VITROS Analyser System 23rd December 2024 Multiple clinical chem and Immunoassay analysers Model: Not Applicable MHRA reference: 34293148    2024/012/023/601/099
6. Spacelabs Healthcare: Eclipse Pro and Eclipse Mini 9611295-11152024-001-C Model: 98700 and 98900 MHRA reference: 34293178    2024/012/024/601/009
7. Ultragel: AquaUltra Basic 20th December 2024 MHRA reference: 34277757   2024/012/020/601/108

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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