Field Safety Notices (FSNs): 13/11/23 – 17/11/23

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 Recall: 3M™ Peltor™ X-series P5 Over the Ear Earmuffs (helmet attached) (2308-0018)

2.     Product Safety Report: Little Laughs Moses Basket sold via Amazon (2308-0141)

Section 2: medical devices 13/11/23 – 17/11/23

1. 2SAN: Flowflex SARS-CoV-2 Antigen Rapid Test 45239 MHRA reference: 27570680
2. Abbott: Assurity, Endurity 45200 Dual -chamber impl. Pm Model: PM2152, PM2162, PM2172, PM2272 MHRA reference: 27580825
3. Actim: PARTUS TEST 45243 Insulin-like growth factor binding protein 1 kit MHRA reference: 27577919
4. BD: CD11b APC 45225 Multiple mature lymphocyte cell marker IVD, kit MHRA reference: 27502820
5. bioMérieux: BIOFIRE FILMARRAY TORCH 45232 Thermal cycler nucleic acid amplification analyzer Model: Shipping Configuration: HTFA-ASY-0001, Part Number: HTFA-ASY-0104 MHRA reference: 27514630
6. Cepheid: Xpert Xpress CoV-2/Flu/RSV plus 45216 MHRA reference: 27519669
7. GE Healthcare: Definium Tempo – Definium Tempo Pro 45240 Stationary basic diagnostic x-ray system, digital MHRA reference: 27577197
8. Getinge: Cardiohelp-I 45240 Heart-lung bypass System Model: 701048012; 701072780 MHRA reference: 27566468
9. Getinge: Cardiohelp-I 45225 Heart-lung bypass System Model: 701048012; 701072780; 701052044 MHRA reference: 27509524
10. Kirchner & Wilhelm: SwiSto3 45223 Iontophoresis systems MHRA reference: 27560938
11. Medtronic: Guardian 4 Sensor / HCP letter November 2023 FA1379 MHRA reference: 27565141
12. Medtronic: Guardian 4 Sensor / User letter November 2023 FA1379 MHRA reference: 27565141
13. mo-vis: Scoot Control 45240 Model: P015-61 & P015-71 MHRA reference: 27548845
14. Ortho Clinical Diagnostics: Ortho BioVue System Control (RH/K II) Cassette 45008 Multiple blood grouping IVD kit, agglutination MHRA reference: 5134536
15. Philips: Brilliance CT Big Bore; Philips CT Big Bore 45238 Full-body CT system Model: 728242, 728243, 728244 MHRA reference: 27561941
16. Philips: HeartStart Intrepid Monitor/Defibrillator 45209 Defibrillators Model: 867172 MHRA reference: 27478214
17. Philips: Patient Information Center iX 45155 Model: 866389, 866390, 867093, 867154 MHRA reference: 27560720
18. Randox: CALIBRATION SERUM LEVEL 3 (CAL 3) 45243 Multiple clinical chemistry analyte IVD, calibrato MHRA reference: 27577830
19. Randox: Specific Protein Control Levels 1-3 44887 Multiple clinical chemistry protein IVD, control MHRA reference: 5193136

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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