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Manufacturers’ Field Safety Notices
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Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
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 18/11/24 – 22/11/24
- Beckman Coulter: Access Intact PTH (Reagent Pack) 45610 DxI 9000 Access Immunoassay Analyzer Model: A16972 Batch/LOT: Refer to Appendix A in the FSN 24060 letter MHRA reference: 33980685 2024/011/019/601/101 MHRA reference: 33980685 – Vigilance response form
- Becton Dickinson: BD FACSLyric™ Flow Cytometers 45621 Flow cytometry analyser IVD Model: Refer to FSN MHRA reference: 34004369 2024/011/021/601/073
- Breas Medical: Vivo 45 LS (non-US) and Nippy 4+ Devices 45614 Portable ventilator, electric Model: Refer to FSN MHRA reference: 33954559 2024/011/015/601/075
- CEFALY Technology: Cefaly Enhanced 45540 Neurologic physiotherapy devices-other; Electrode Model: Refer to FSN MHRA reference: 33986095 2024/011/019/601/060
- Cook Medical: Hemospray Endoscopic Hemostat 45595 Non-organic haemostatic agent, sterile LOT number: Refer to attachment MHRA reference: 33983609 2024/010/023/601/109 MHRA reference: 33983609 – Lot numbers
- DiaSorin Inc.: LIAISON QSET Device Plus FSN-2024-03 Calprotectin IVD, reagent Model: Refer to FSN MHRA reference: 33993447 2024/011/011/601/019
- ICU Medical: Plum 360™ Infusion System 21st November 2024 Model: Refer to FSN MHRA reference: 33965399 2024/011/018/601/007
- NIHON KOHDEN: ECG Recording Paper 45617 Interpretive multichannel electrocardiograph Model: NKUK-A054 and NKUK-MLSC-125 MHRA reference: 34007941 2024/011/021/601/023 MHRA reference: 34007941 – Receipt
- Philips: Spectral CT, Spectral CT Plus 45604 Full-body CT system Model: Refer to FSN MHRA reference: 33952265 2024/011/015/601/008
Section 3: medical devices 25/11/24
- RRR Manufacturing Pty Ltd: CellAED® 45621 Automated External Defibrillator Model: CellAED 100-2.2-094 MHRA reference: 34027855 2024/011/025/601/094
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
| Page summary | Change(s) made |
| n/a | n/a |
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/
Kind regards
Incident Reporting & Investigation Centre (IRIC)
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575 | nss.iric@nhs.scot
IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video
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 in our NSS Strategic Framework 2024-2026
FAC406-212, 8B(i), Rev 7
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