Field Safety Notices (FSNs): 06 to10 February 2023

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. Aidapt Deluxe Lightweight Self-Proppelled and Aidapt Compact Transport Attendant-Propelled Aluminium Wheelchairs sold by Argos (2301-0190) – for awareness within community settings
2. Product Recall: 3M™ Versaflo™ A2B2E2K1HgP Filter, TR-6580E (2212-0126) – for awareness of estates & facilities and laboratory staff

Section 2: medical devices 06/02/23 – 10/02/23

3. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / HCP Letter 44966 MHRA reference: 5056305 HCP Letter
4. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Impacted User Letter 44966 MHRA reference: 5056305 Impacted User Letter
5. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Non-Impacted User Letter 44967 Model: VA170 & VA165Silver MHRA reference: 5056305 Non-Impacted User Letter
6. Abbott: CardioMEMS Patient and Hospital Electronics System FA-Q123-HF-1 Electronics System Emissions February 2023 Model: CM1000, CM1100, CM3000 MHRA reference: 5050353
7. Abbott: CardioMEMS PA Sensor and Delivery System 44958 Model: CM2000 MHRA reference: 5049410
8. Baxter: Y-Type Blood/Solution Infusion Sets 44897 MHRA reference: 5048643
9. Baxter: 1.5% Glycine for Irrigation 3000ml, 0.9% Sodium Chloride (NaCl) for Irrigation 3000ml 44911 MHRA reference: 5048168
10. BD: Infusion Sets – MicroSet 44966 MHRA reference: 5050337
11. BD: Alaris GP Plus Guardrails Pump & BD Alaris™ neXus GP Pump 45260 MHRA reference: 5048713
12. GBUK Healthcare: Silicone Pessary 44900 Model: G64#4, G70#5, G76#6 MHRA reference: 5048105
13. Getinge: Volista STANDOP 44687 MHRA reference: 5006365
14. Medtronic: Dermalon Monofilament Nylon sutures Monosof Monofilament Nylon sutures Novafil Monofilament Polybutester Suture Sofsilk Coated Braided Silk Suture Surgilon Braided Nylon suture Surgidac Uncoated Braided Polyester suture Surgipro Monofilament Polypropylene Sutures Surgipro II Monofilament Polypropylene Sutures Ti-Cron Coated Braided Polyester Suture 44896 MHRA reference: 5041299
15. Medtronic: Evolut PRO+ Transcatheter Aortic Valve (TAV) FA1290, December 2022 MHRA reference: 5048691
16. Medtronic: SmartPill SmartBar 44958 Model: FGS-0505 MHRA reference: 5052010
17. Medtronic: Medtronic MiniMed Paradigm Infusion Pumps / HCP Letter 44927 Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722; MMT-554, MMT-754 MMT-508 MHRA reference: 5044039 HCP Letter
18. Medtronic: Medtronic MiniMed Paradigm Infusion Pumps / User Letter 44927 Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722; MMT-554, MMT-754 MMT-508 MHRA reference: 5044039 User Letter
19. PerkinElmer: DELFIA Inducer 44964 Model: 3027-0010 MHRA reference: 5052000
20. Siemens Healthineers: ARTIS pheno, ARTIS icono biplane/icono floor 44896 MHRA reference: 5044072
21. Siemens Healthineers: ARTIS pheno 44927 MHRA reference: 5049324
22. Siemens Healthineers: Atellica DCA HbA1c Dx Reagent POC 23-006.A.OUS, February 2023 MHRA reference: 5050447
23. Stryker: LIFEPAK® CR2 DEFIBRILLATOR 44958 MHRA reference: 5050356
24. SynCardia: SynCardia Total Artificial Heart System 44960 MHRA reference: 5048183

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