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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 13/02/23 – 17/02/23
- B Braun: INF.SP.LINE,TRANS,PVC,LL,250CM-EU 44936 MHRA reference: 5065106
- CareDx: Olerup SSP HLA-A-low 44972 MHRA reference: 5058158
- Cook Medical: MINC+ Benchtop Incubator 44960 Model: K-MINC-2000 MHRA reference: 5056548
- CU Medical Systems: iPAD 44951 Model: CU-SP1, CU-SP1 AUTO MHRA reference: 5038245
- DiaSource: Chromogranin A RIA 44966 MHRA reference: 5079270
- Euromi: NLF system kit EN7-D-003 – 001 – NLF232FE11 Model: NLF 2 MHRA reference: 5056651
- Medtronic: Monopolar Curved Shears 44958 Model: MRASI0001 MHRA reference: 5080174
- Phoenix: Volumed Set 44910 MHRA reference: 5050330
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
Please consider the environment before printing this email.
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
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