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 Recall: Lenovo USB-C Laptop Power Bank (2311-0234)

2.    Product Safety Report: Reflective outdoor safety belt/harness sold via Etsy (2311-0085)

3.     Product Recall: Clinisan Bodywash (2311-0232)

4.    Product Safety Report: Eterna SEMEM3 Self-Test Emergency Bulkhead (2311-0098)

Section 2: medical devices 27/11/23 – 01/12/23

1. Abbott: ID NOW Instrument 45200 Isothermal nucleic acid amplification analyser IVD MHRA reference: 27607209     2023/010/019/601/031
2. B Braun: Standard and customer specific Combitrans/Combidyn 45259 Invasive blood pressure transducer set MHRA reference: 27631634     2023/011/030/601/014
3. Balt Extrusion: FARGO / CRISTAL BALLOON 45133 Model: FRG6F115_8MP / CBV18X40/110 MHRA reference: 27607543     2023/011/028/601/047
4. Boston Scientific: Model 3120 ZOOM PRM with Model 2892 Software 45260 Program.Record.Monitor(PRM)for Impl. PulseGenerat. Model: 3120 MHRA reference: 27632171     2023/011/030/601/066
5. Cook Medical: Tuohy-Borst Adapter 45264 In-line backflow valve, single-use Model: TBAYR-6 MHRA reference: 27632032     2023/011/030/601/060
6. Exactech: TIBIAL INSERT MB SZ 3 RT 6MM 45252 MHRA reference: 27602176     2023/011/024/601/033
7. Illumina: MiSeq Dx Instrument FSN2023-1452 Nucleic acid sequence analyser IVD, NGS MHRA reference: 27604102     2023/010/025/601/025
8. Össur: Power Knee Battery 45260 Motorized External Knee Prosthesis Model: PKA10002 MHRA reference: 27631722     2023/011/030/601/062
9. Philips: Trilogy Evo and Trilogy Evo O2 ventilators 45231 Portable Electric Ventilator MHRA reference: 27632591     2023/011/030/601/032
10. Randox: COPPER (Cu) 45259 Copper IVD, kit, spectrophotometry MHRA reference: 27621466      2023/011/029/601/035
11. Sentinel Diagnostics: IRON, IRON, Alinity c Iron Reagent 45198 Iron IVDR, kit, spectrophotometry MHRA reference: 27622265     2023/010/002/601/066
12. Siemens Healthineers: Sensis 45231 Cardiac catheterization laboratory computer MHRA reference: 27622356     2023/011/029/601/051
13. Smiths Medical: Medfusion Model 3500 Syringe Infusion Pump 29 November 2023 FA2310-02 MHRA reference: 27633824     2023/011/027/601/008
14. Smiths Medical: Medfusion Model 4000 Syringe Infusion Pump 45259 MHRA reference: 27607213        2023/011/027/601/007
15. ThermoFisher Scientific: Mueller Hinton + Horse Blood + NAD (4MM) 45253 MHRA reference: 27604138     2023/011/027/601/027

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  

FAC406-212, 8B(i), Rev 6

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