Field Safety Notices (FSNs): 14/08/23 – 18/08/23

Manufacturers’ Field Safety Notices

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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: Schneider Electric – Compact Moulded Case Circuit Breaker (2308-0038)
2. Product Recall: Poukey Replacement Charger for Samsung Galaxy sold via Amazon (2302-0088)
3. Product Safety Report: Nibbling Silicone Dummy Clip – Geo (2306-0063)
4. Product Safety Report: Baby Playpen Safety Yard Activity Centre with Basketball Hoop sold via eBay (2307-0119)
5. Product Recall: My Babiie MB30 Pushchair (2308-0031)

Section 2: medical devices 14/08/23 – 18/08/23

1. Abbott: Gallant, Neutrino, Entrant 45139 Defibrillator, Implantable, biventricular Model: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, CDHFA300Q MHRA reference: 13385832 2022/005/017/611/003
2. Baxter: EVO IQ Large Volumetric Pump 45145 Infusion pump, general-purpose Model: ELVP001UKI (applicable in UK) ELVP001GRC MHRA reference: 8911964 2023/008/004/601/008
3. Berlin Heart: EXCOR Cannulae 45139 Circulatory assist unit ventricular MHRA reference: 12468950 / 2023/008/014/601/022
4. Fujifilm: Synapse PACS Ref 20220930 Picture archiving and communication system, radiology MHRA reference: 5139849 2023/003/029/601/035
5. Siemens Healthineers: ADVIA Chemistry Iron_2 (IRON_2) Reagents 45139 Iron IVD, kit, spectrophotometry MHRA reference: 12038929 / 2023/008/011/601/023

Werfen: HemosIL AcuStar ADAMTS13 45104 MHRA reference: 13313949

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. 

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/  

​Incident Reporting & Investigation Centre (IRIC) 

​Facilities Division

NHSScotland Assure

​NHS National Services Scotland 

​Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn

​  

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 about our services at www.nss.nhs.scot  

FAC406-015, 8B(i), Rev 6

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