Field Safety Notices (FSNs): 09/01/23 – 13/01/23

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 09/01/23 -13/01/23

1.    3M: Ranger Blood/Fluid Warming High Flow Sets 44872 MHRA reference: 5013122

2. Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e 44911 MHRA reference: 4907224
3. Getinge: Clean Enzymatic 44853 Model: XV1559 MHRA reference: 5006455
4. Grena Biomed: NE`X Glue Surgical Adhesive 44925 Model: 0206-NX2; 0206-NX5; 0206-NX10 MHRA reference: 4927365
5. Hologic: 3Dimensions and Selenia Dimensions 44928 Model: 3DM-SYS-INTL2D-MOBSDM-SYS-9000-2D3DM-SYS-INTL2D3DM-SYS-INTL3DSDM-00001-2DSDM- SYS-9000-3DSDM-00001-M2D MHRA reference: 5013084
6. implantcast: MUTARS HD coupling Brand 44908 Model: 57201230N, 57201232N, 57201233N MHRA reference: 5006338
7. Medtronic: Vanta LT Clinician Programmer Application 44866 Model: A71200 MHRA reference: 4617979
8. Medtronic: Mahurkar™* Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar QPlus) 44896 MHRA reference: 5013118
9. Miethke: M.blue plus 44935 MHRA reference: 5013351
10. MOBIDIAG: Novodiag Bacterial GE+ 44915 Model: V5 MHRA reference: 5013097
11. Ortho Clinical Diagnostics: ORTHO VISION and VISION Max Analyzers for BioVue 44918 MHRA reference: 4849774
12. Oxehealth: Vital Signs 44896 Model: Vital Signs 1 MHRA reference: 5013354
13. Philips: Ingenia Elition, MR 7700 44887 Model: 781358, 782107, 782119, 782136, 781357, 782106, 782137, 782118, 782132, 782144, 782120, 782130 MHRA reference: 5013417
14. Randox: IgA and IgM 44860 MHRA reference: 5013107
15. Siemens Healthineers: SOMATOM go.Top/ x.cite CT083/22/S MHRA reference: 5004526
16. Siemens Healthineers: Artis zee / Q / Q.zen 44896 MHRA reference: 4638589
17. Smiths Medical: CADD Infusion System Infusion Sets for use with CADD pumps 44908 MHRA reference: 5013072
18. SSI Diagnostica: ImmuLex Pneumotest Kit 44888 MHRA reference: 4643952.
19. ….
20. ….
21. ….

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