Field Safety Notices (FSNs): 29/07/24 – 02/08/24

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

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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

1. Product Recall: LIQAL Boil-off Gas Treatment Unit (BTU) (2404-0194)

2.    Product Recall: 700HPM High Pressure Calibration Manifold (2407-0092)

Section 2: medical devices 29/07/24 – 02/08/24

1. Abbott: HeartMate 3 System Controller 45474 Heart Ventricle Prosthesis 106524INT, 106531INT, 106531LF2 MHRA reference: 31376846    MHRA reference: 31376846 – Letter
2. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 19th July 2024 See Section 8 C11137 MHRA reference: 31364293   MHRA reference: 31364293  –  Vigilance Response Form
3. Beckman Coulter : IRISpec CA/CB/CC 19th July 2024 Multiple urine analyte IVD, control 800-7702 MHRA reference: 31372911   MHRA reference: 31372911 –   Vigilance Response Form
4. Beckman Coulter: IRISpec CA/CB/CC 1102 Multiple urine analyte IVD, control 800-7211 (NORTH AMERICA), 800-7702 (INTERNATIONAL) MHRA reference: 31376942 – Customer letter    MHRA reference: 31376942 – Vigilance Response Form
5. Beckman Coulter: Access HBc Ab 24th July 2024 See Section 8 Model: 34240  MHRA reference: 31381600     MHRA reference: 31381600    MHRA reference: 31381600  –   Vigilance Response Form
6. Carl Reiner: EasyConnect™ Adapter for 2 to 4 Lumen Jet Catheter 4th July 2024 Adaptor, endoscope element MHRA reference: 31377372 
7. GE HealthCare: Proteus XR/a FMI 17144 Stationary basic diagnostic x-ray system, analogue MHRA reference: 31378512 
8. Laborie: Flowstar 16th July 2024 Model: U2-1 MHRA reference: 31369249  
9. MEGADYNE: See Attachment 3 16th June 2024 Electrosurgical return electrode, reusable MHRA reference: 31362659 
10. Medevio: Blueflow Venous Stent devices 19th July 2024 FG-02234-004A MHRA reference: 31377374  
11. Paradigm Spine: HPS 2.0 Rod coupler, S=25N/mm, 27mm 45474 Spinal dynamic-stabilization system MHRA reference: 31376875   
12. Schiller: CARDIOVIT AT-180 23rd July 2024 Electrocardiograph, professional, multichannel 3.92057 MHRA reference: 31366042 
13. THOR Photomedicine: NovoTHOR and NovoTHOR XL 19th April 2024 Phototherapy unit, red light, line-powered Model: S2188 and S2190  MHRA reference: 30919715

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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