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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 13/03/23 – 17/03/23
- Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App/ HCP Resolution Letter FSLL Resolved FSL3 Pending 44980 Invasive Interstitial-fluid glucose monitoring system MHRA reference: 5099927
- Athrodax Healthcare International: I.B.S 3.0-C Compression screw – diam 3.0mm lg28mm 44985 Orthopaedic bone screw, non-bioabsorbable, sterile Model: S30 ST128 MHRA reference: 5100570
- Belmont Medical Technologies: Rapid Infuser, RI-2 1000 ml/min,750 ml/min 44981 Infusion pump, high-flow, warming Model: 903-00037A and 903-00039A MHRA reference: 5090583
- Biocartis: Idylla Instrument Test 44999 NUCLEIC ACID TESTING INTEGRATED EXTRACTION / AMPLI MHRA reference: 5101652
- Draeger: Infinity CentralStation, Infinity M300/M300+ 44986 Physiological Monitoring Systems Model: MS18348, MS25707, MS32504, MS25755, MS26031, MS26076, MS33659, MS32504, MS33648 MHRA reference: 5101188
- Full Vision: Trackmaster Treadmills 44893 MHRA reference: 5052085
- Getinge: Cardiosave Intra-Aortic Balloon Pumps 44965 Circulatory assist system, intra-aortic balloon Model: 0998-XX-0800-XX MHRA reference: 5052013
- Getinge: QUADROX-i/-iD | VHK 11000 44998 Oxygenator, extracorporeal membrane MHRA reference: 5101657
- GS Elektromedizinische Geräte G. Stemple GmbH: corpuls3 Technical Bulletin No. 023 Physiologic-monitoring defibrillation system Model: 04100, 04100.1, 04100.2, 04101, 04200, 04200.1, 04200.2, 04201, 04300, 04300.1, 04300.2, 04301, 04302, 04303, 04304, 04305 MHRA reference: 5101440
- Iradimed: MRidium 1057 MRI Syringe Adapter Set 44995 MHRA reference: 5100797
- Lavender Medical: I.B.S® 3.0-C Compression screw – diam 3.0mm lg28mm 44985 Orthopaedic bone screw, non-bioabsorbable, sterile Model: S30 ST128 MHRA reference: 5100570
- Podonics: Dispence Applicator – Phenol Blue 89% 44979 Model: PDP89B MHRA reference: 5097902
- Quidel: MicroVue C1-Inhibitor Plus EIA 44953 Model: A037 MHRA reference: 5101843
- Radiometer: AQURE system FAN 915-424 Model: 933-599 MHRA reference: 5094720
- RESORBA: GENTA-COLL resorb, PARASORB RESODONT Forte, PARASORB RESODONT, GENTA-FOIL resorb, KOLLAGEN resorb 45001 MHRA reference: 5101618
- Robinson Healthcare: Instrapac 44937 Tubular bandage applicator Model: Tubegauze Applicator (Medium) MHRA reference: 5082085
- Roche: cobas pure e 402 analytical unit, cobas e 801 analytical unit, cobas e 801 module, cobas pure sample supply unit, cobas pro sample supply unit, cobas pro SSU, cobas 8000 core unit 44958 MHRA reference: 5090801
- Stryker: LIFEPAK CR2 Defibrillator 44927 MHRA reference: 5052023
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