Field Safety Notices (FSNs): 06/03/23 – 10/03/23

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. Product Recall: BEHA-AMPROBE Multimeters (2303-0015) https://www.gov.uk/product-safety-alerts-reports-recalls/product-recall-beha-amprobe-multimeters-2303-0015?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8e8ab335-15da-4042-b39c-41f8b11fa68f&utm_content=weekly

Section 2: medical devices 06/03/23 – 10/03/23

1. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App/ HCP Resolution Letter FSLL Resolved FSL3 Pending 44980 Invasive Interstitial-fluid glucose monitoring system MHRA reference: 5099927
2. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Customer Resolution Letter Signal Loss Resolution FSL3 44982 Invasive Interstitial-fluid glucose monitoring system MHRA reference: 5099927
3. Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / HCP Resolution Letter Signal Loss Resolution FSL3 44982 Invasive Interstitial-fluid glucose monitoring system MHRA reference: 5099927
4. Armstrong Medical: Neonatal Breathing Circuits 44988 Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified Oxygen Systems, Aquavent Neo nCPAP Systems MHRA reference: 5099946
5. B Braun: CAIMAN 44993 Endoscopic electrosurgical handpiece Model: PL770SU, PL771SU, PL774SU, PL775SU MHRA reference: 5100203
6. Boston Scientific: Habib EndoHPB Bipolar Radiofrequency Catheter 44987 Endoscopic electrosurgical handpiece/electrode MHRA reference: 5097885
7. Brainlab: ExacTrac Dynamic 44951 Radiation therapy software Model: 20910-01E, 20910-01F MHRA reference: 5100531
8. Draeger: Flex ventilation hoses 44927 Tubing MHRA reference: 5097923
9. Eakin Surgical: Diathermy Suction 44973 Endoscopic electrosurgical handpiece/electrode MHRA reference: 5099868
10. Elekta: Monaco RTP System 44958 Radiation therapy application software MHRA reference: 5093513
11. GE Healthcare: Vivid i, Vivid q, Vivid S5, Vivid S6 GEHC Ref# 76194 Ultrasound system, imaging, cardiovascular MHRA reference: 5097827
12. Macopharma: Single or multiple blood bag with LCRD2 filter 44993 In-line red cell filtration system MHRA reference: 5099933
13. Medex: Qitexio – 20ml Luer Lock Syringe 44985 General purpose syringe, single-use MHRA reference: 5100572
14. Objective Imaging: Glissando 44993 Cell morphology analyser IVD, automated Model: Objective Imaging Desktop Scanner MHRA reference: 5100586
15. Philips: Tempus Pro Patient Monitor 44972 Transportable system Model: 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R MHRA reference: 5099402
16. Philips: DigitalDiagnost C50 1.0 & 1.1 44984 Model: 712201, 712204 MHRA reference: 5100634
17. ThermoFisher Scientific: RAPID Hp StAR Kit 44995 MHRA reference: 5100641
18. Winnomed: 1L Latex-Free Breathing Bag and 2L Latex-Free Breathing Bag 44974 Model: 040201, 040202 MHRA reference: 5099324.

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