Field Safety Notices (FSNs): 01/05/23 – 05/05/23

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

None

Section 2: medical devices 01/05/23 – 05/05/23

1. Abbott: Alinity i Anti-TPO Reagent Kit 45040 Thyroid peroxidase antibody MHRA reference: 5201317
2. Corin: Trinity 45029 Acetabular Shell Model: 321.03.352 MHRA reference: 5215882
3. Ellex: Integre Pro Scan Green 44995 Model: LP6G MHRA reference: 5114031
4. Fannin: Fastidious Anaerobic Agar + Horse Blood 45048 MHRA reference: 5216000
5. Getinge: PLS Set; HLS Set Advanced5.0; HLS Set Advanced 7.0 45042 MHRA reference: 5218919
6. illumina: NextSeq 550Dx Instrument / MiSeq Dx Instrument 45021 Nucleic acid sequence analyser IVD, NGS MHRA reference: 5215327
7. Medtronic: HVAD Pump Implant Kit 45047 Implantable Ventricular Circulatory Assist System Model: 1104 MHRA reference: 5217293
8. Moller: Drainage Set LiquoGuard 7 45009 Model: 00003501 1411 MHRA reference: 5196943
9. NOxBOX: NOxBOXi 45049 MHRA reference: 5215954
10. Raysearch Laboratories: RayStation 44964 Various Radiotherapy Instruments – Software Model: RayStation 4 – 11B and RayPlan 1, 2, 7 – 11B and Service Packs MHRA reference: 520114
11. Thermo Fisher Scientific: Cascadion SM Clinical Analyzer 45049 CHEMISTRY ANALYSERS – LOW ROUTINE MHRA reference: 5223155
12. Timesco: Easy Bright Bld & P’loaded Hdl Sets (Mac & Miller) 45049 Rigid intubation laryngoscope, single-use MHRA reference: 5215953
13. Tracoe: TRACOE experc Set twist, twist plus, vario 44950 MHRA reference: 5216068

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