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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 02/10/23 – 06/10/23
- Abbott: CardioMEMS Patient Electronic System / HCP Letter 45200 Implantable pulmonary artery pressure monitoring Model: CM1100 MHRA reference: 27438333
- Abbott: CardioMEMS Patient Electronic System / Patient Letter 45200 Implantable pulmonary artery pressure monitoring Model: CM1100 MHRA reference: 27438333
- Arthrex: Knee Scorpion 45155 Suturing unit, reusable Model: AR-12990 MHRA reference: 27393151
- Boston Scientific: EXALT Model D Single-Use Duodenoscope 45202 Flexible video duodenoscope, single-use MHRA reference: 27432136
- GE Healthcare: Venue Go 45197 Ultrasound system, imaging, general-purpose MHRA reference: 27427645
- Getinge: APERLAN PY AGENT A, APERLAN PY AGENT B 45142 Disinfectant, medical device MHRA reference: 27421190
- Getinge: CARDIOHELP Emergency Drive 45204 Heart-lung bypass System Model: 701048002; 701076205 MHRA reference: 27441143
- Getinge: CARDIOHELP-I 45160 Heart-lung bypass System Model: 701048012, 701072780 (US Variante) MHRA reference: 27437628
- Integra: Codman CereLink ICP Monitor 21 September 2023 FSN 2022-HHE-006 A Intracranial pressure monitor Model: 826820 MHRA reference: 27440092
- Integra: Codman CereLink ICP Monitor 21 September 2023 FSN 2022-HHE-006 B Intracranial pressure monitor Model: 826820 MHRA reference: 27440092
- Roche: Accu-Chek Solo reservoir / HCP Letter 45180 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS MHRA reference: 27367252
- Roche: Accu-Chek Solo reservoir / Patient Letter 45180 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS MHRA reference: 27367252
- Vitalograph: BVF 45168 Model: 2820 MHRA reference: 27422397
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)
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
FAC406-015, 8B(i), Rev 6
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