Field Safety Notices (FSNs): 05/06/23 – 09/06/23

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: SALVUS Micropoint Gas Cooker Hoses (2305-0120)

Section 2: medical devices 05/06/23 – 09/06/23

1. Altomed: Damato Ruthenium Plaque Template 45072 Eye brachytherapy plaque-/applicator-positioning Model: A7075CIB, A7075CIA, A7075COC MHRA reference: 5296456
2. Baxter: Allen Advance Chest Support w/pad 45083 Surgical positioning spine board MHRA reference: 5302171
3. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 45077 Chemiluminescent immunoassay analyser IVD, automated MHRA reference: 5300761
4. bioMérieux: EBV R-GENE – BK Virus R-GENE 45082 MHRA reference: 5296460
5. Click Medical: RevoLock Align Kits and RevoLock 4-Hole Kits 45068 Model: threaded insert and snap MHRA reference: 5296424
6. Macopharma: Single or multiple blood bag with LCRD2 filter 45079 In-line red cell filtration system MHRA reference: 5301297
7. Medical Innovation Development: Medical Innovation Development / MIDBAND 45051 Gastric Band Model: Adjustable Gastric Band MHRA reference: 5240834
8. Medtronic: Vanta with AdaptiveStim Technology FA1340 June 2023 Spinal cord/peripheral nerve implantable analgesic Model: 977006 MHRA reference: 5301164
9. Medtronic: Cytosponge Cell Collection Device 45078 Cytology Scraper, single use Model: CYTO-201 MHRA reference: 5296419
10. Philips: Azurion, Allura Xper 45082 Interventional Fluoroscopic X-Ray System Model: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035, 722079, 722224 MHRA reference: 5303178
11. Philips: HeartStart Intrepid Monitor/Defibrillator 45062 Defibrillators Model: 867172 MHRA reference: 5303186
12. Poly Medicure: Polyflush Syringe, 0.9% Sodium chloride (0.9% NaCl), (Saline Solution Pre-Filled Syringes Single Sterile) 45064 MHRA reference: 5302580
13. Therapy Equipment: 0-15LPM Diamond Flowmeter FSCA 2022-1_9505 Diamond Flowmeter Diamond Flowmeter Model: 9505 MHRA reference: 5005603
14. Thermo Fisher Scientific: Bilirubin Total (DCA) 45078 Total bilirubin IVD, kit, spectrophotometry MHRA reference: 5296426
15. Thermo Fisher Scientific: RapID STR System 45079 MHRA reference: 5296441
16. Zimmer Biomet: Betta Link 45039 MHRA reference: 5303214

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 

​Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts

​  

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  

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

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