Field Safety Notices (FSNs): 15/04/24 – 19/04/24

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: Beha-Amprobe MT204-S with Test Leads (2403-0027)

2.    Product Recall: Solar Group 1 2 3 Isofix Car Seat (2404-0080)

Section 2: medical devices 15/04/24 – 19/04/24

1. BD: neXus V700 Infusion Pump 45393 MHRA reference: 29270774
2. Bolton Surgical: Rampley Sponge Forceps FSN 240204a Dressing/utility forceps, scissors-like, reusable Model: WO373604-1597 to 1611 MHRA reference: 29275487     
3. Bolton Surgical: Mosquito Artery Forceps  FSN 240204b  Surgical soft-tissue manipulation forceps   Model: 11-1512-06    MHRA reference: 29282541   
4. Bolton Surgical: Weislander Self Retaining Retractor  FSN 240204c  Self-retaining surgical retractor, reusable  Model: 11-2033-00   MHRA reference: 29283261    
5. Bolton Surgical: Mcindoe Dissecting Forceps FSN 240204d Surgical soft-tissue manipulation forceps Model: WO373607-300 to 301 MHRA reference: 29275592    
6. Boston Scientific: Vercise Genus Implantable Pulse Generator System 45400 Deep brain electrical stimulation system  Model: DB-1216 and DB-1232  MHRA reference: 29289976 
7. In2Bones: NeoFit screw 45390 Model: V30 ST112 & V30 ST114 MHRA reference: 29270452   
8. Leica: HistoCore Pegasus / HistoCore Pegasus Plus 45399 Tissue processor IVD, automated Model: HistoCore Pegasus: G0061 – G0154, G0156 – G0530, G0532 – G0779, G0781, G0782 HistoCore Pegasus Plus: P0061 – P0080, P0082 – P0116, P0119 – P0156, P0158- P0164, P0166 – P0201, P0203 – P0232, P0234 MHRA reference: 29275596   
9. Medcaptain: Infusion Pump /Syringe Pump 45377 Model: BD neXus V700 Infusion Pump /BD neXus S700 Syringe Pump MHRA reference: 29270326 FSN    MHRA reference: 29270326 Serial numbers
10. Olympus: TFL Fiber Cleaver, TFL Fiber Stripper/ Olympus 45292 General/multiple surgical solid-state laser system Model: TFL-AFC, TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 MHRA reference: 29272060     
11. Philips: 5000 Compact Series Ultrasound Systems 45371 General-purpose ultrasound imaging system Model: 795141, 795143, 795144, 795145, 795146, 795147, 795148 MHRA reference: 29275595     
12. Thermo Fisher: D-Dimer Calibration Set 45399 D-dimer IVD, calibrator MHRA reference: 29289973
13. Zimmer Biomet: NexGen CR-Flex porous or NexGen CR-Flex Fiber Metal Mesh Femur 45394 Coated knee femur prosthesis MHRA reference: 29270455

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/  

​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 7

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