Field Safety Notices (FSNs): 29 April to 3 May 2024

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

1. None

Section 2: medical devices 29 April to 3 May 2024

1. Arrow International: FiberOptix Ultra 8 IAB Ultra 8 IAB UltraFlex IAB 45383 Intra-aortic balloon catheter   MHRA reference: 29529909
2. Cepheid: Xpert Carba-R 45377 MHRA reference: 29529992   
3. GE Healthcare: Carescape multi-parameter patient monitors   Ref. # 36161 Single-patient physiologic monitoring systems   MHRA reference: 30165752     2024/004/030/601/062 
4. INTEGRA: Integra Cranial Access Kit without drugs, bits  45392 Craniotomy Kit  MHRA reference: 29528832     2024/004/012/601/007 
5. Medtronic: Minimed Insulin Pump May 2024 FA1249 MHRA reference: 30156053    2022/005/026/599/007 
6. Olympus: INSTACLEAR SHEATH 45415 Endoscope lens cleaner, gas/fluid, single-use Model: LCS4K00UNOL LCS4K45BTOL LCS4K45TPOL LCS1500UNOL LCS1530BTOL LCS1530TPOL LCS4K30BTOL LCS4K30TPOL LCS1545BTOL LCS1545TPOL LCS1570BTOL LCS1570TPOL LCS4K70BTOL LCS4K70TPOL LCS1830BTST LCS1830TPST LCS1845BTST LCS1845TPST LCS1870BTST LCS1870TPST LCS1800UNST MHRA reference: 29529876     2024/004/029/601/107 
7. Zhejiang Innuovo Rehabilitation Devices: Innuovo Power Wheelchair 45412 Model: W5521 MHRA reference: 29545774     2024/003/029/601/003

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

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  

FAC406-212, 8B(i), Rev 7

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