Field Safety Notices (FSNs): 15/05/23 – 19/05/23

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: Bluebell Baby Monitors (2305-0084)

2.   Product Recall: Badabulle Foldable Bath Seat (2304-0140)

Section 2: medical devices 15/05/23 – 19/05/23

1. Bridge to Life: Belzer UW Cold Storage Solution & Belzer MPS 45047 MHRA reference: 5239376
2. Draeger: Oxylog 3000 plus 45047 Ventilators, Transport MHRA reference: 5235382
3. Medline: Sterile Ultrasound Gel 45058 MHRA reference: 5233673
4. Ortho Clinical Diagnostics: VITROS Chemistry Products HbA1c Reagent CL2023-096a_EU Glycated Hb(HbA1c)IVD kit,nephlometry/turbidimetry MHRA reference: 5236910
5. RAL Diagnostics: Buffer solution for automated systems 45022 Model: 75050SX5000; 75050SX7010; 75040SX5000 MHRA reference: 5196884
6. Roche: Elecsys® Troponin T hs / Elecsys Troponin T hs STAT: discrepant elevated results with certain plasma EDTA primary tubes 44927 MHRA reference: 5205171
7. SCHILLER: SCHILLER FRED PA-1 DEFIBRILLATOR 45017 Model: FRED PA-1 MHRA reference: 5236202
8. Siemens Healthineers: Aptio Automation Storage and Retrieval Module 45047 Specimen processing instrument IVD, automated < MHRA reference: 5239339
9. Terumo Aortic: TREO Abdominal Stent-Graft System 45058 Abdominal aorta endovascular stent-graft MHRA reference: 5216917
10. ThermoFisher Scientific: EliA GBM Well QA2023-05 May 2023 Glomerular basement membrane antibody IVD, kit Model: 14-5514-01 MHRA reference: 5235366

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)

Health Facilities Scotland

NHS National Services Scotland

Contact us:

IRIC Email         nss.iric@nhs.scot

Helpline             0131 275 7575

Web                 https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts

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NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org

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