Field Safety Notices (FSNs): 19/02/24 – 23/02/24

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. None

Section 2: medical devices 19/02/24 – 23/02/24

1. Abbott: HeartMate 3 and HeartMate 2 45323 Heart Ventricle Prosthesis   Model: 106524, 106524INT, 106015,106016,102139, 103695, 104912, 103693 MHRA reference: 28008445   
2. AusDiagnostics: Step 2 Plates for Respiratory Pathogens 24-well  45337 Multiple-type respiratory pathogen nucleic acid   MHRA reference: 28007636
3. CooperSurgical: Origo Sperm Wash Media 45338 MHRA reference: 28028404
4. EMS: NIGHT CLEANER Bottle, PIEZON Bottle, WATER Bottle  45344 Dental abrasive air jet system / Ultrasonic dental  Model: EG-111, EG-120 and EG-121 MHRA reference: 28023118   Customer letter   MHRA reference: 28023118   Distributor letter 
5. Intersurgical: FILTANEB, CIRRUS2 NEBULISER, ADULT, INTERSURGICAL 45342 Nebulizing system delivery set, single-use MHRA reference: 28013466
6. Ivoclar: Bluephase Style 45331 MHRA reference: 28023975    
7. Philips: DIVA 24 Inch Widescreen LCD Touch Display  45337 Model: RGD2461AMI/Philips Part #866126 MHRA reference: 28020646   
8. Randox: Immunoglobulin M SUBCLASS (IgM SUBCLASS) IVD, kit   45337 IgM   MHRA reference: 28007831   
9. Vygon: POLYPERF SAFE (PPS) 45343 Needle, subcutaneous injection/infusion port   Model: 601709 and 602509 MHRA reference: 28024052   
10. ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm   45191 MHRA reference: 28023966

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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