Field Safety Notices (FSNs): 21/08/23 – 25/08/23

Manufacturers’ Field Safety Notices

Circulation

NHS incidents and alerts safety officer

Local authority incidents and alerts safety officers

IRIC product specialists

IRIC alerts general list

Specialist liaison list

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: Bop Bop Baby Lion Teether & Pacifier Clip Set sold by TK Maxx (2308-0133)

Section 2: medical devices 21/08/23 – 25/08/23

1. Abbott: Apical Coring Knife 45139 Heart Ventricle Prosthesis Model: 106524INT MHRA reference: 24572577
2. B Braun Medical: Infusomat Space 45139 Bedside infusion pump, single-channel MHRA reference: 23831841
3. B Braun Medical: Spaceplus Infusomat 45139 Bedside infusion pump, single-channel MHRA reference: 23363353
4. DePuy Synthes: BioKnotless Anchor 45017 Model: 212724, 212725, 212726, 212722, 212723 MHRA reference: 22192340
5. Drager: Babyroo TN300 45139 Infant Warmer MHRA reference: 20503932
6. Getinge: MEERA operating table with autodrive 45139 Universal operating table, electrohydraulic Model: 7200.01B2, 7200.01F2, 7100.01B2 MHRA reference: 13515945
7. Invivoscribe: LymphoTrack Dx IGH – MiSeq 45139 Model: 91210109 – LymphoTrack Dx IGH FR3 Assay – Kit A – MiSeq, 91210119 – LymphoTrack Dx IGH FR3 Assay – Panel – MiSeq, 91210129 – LymphoTrack Dx IGH FR1/2/3 Assay – Kit A – MiSeq, 91210139 – LymphoTrack Dx IGH FR1/2/3 Assay – Panel – MiSeq MHRA reference: 25619485
8. Medtronic: Palindrome Chronic Catheter Kit Symmetrical Tip 14 45139 Double-lumen haemodialysis catheter, implantable Model: 8888145015 MHRA reference: 23404435
9. Medline International France: Hudson RCI AQUAPAK Humidifier Adaptors 45139 MHRA reference: 22072866
10. Oculus: Pentacam AXL Wave 45139 Corneal Surface Measurement System Model: 70100, 70020 MHRA reference: 20304382
11. Ossur: Icelock Ratchets 45017 Extern lower-limb prosthesis suspensory component Model: L-125000; L-621200; L-621000; L-621100; L-692020 MHRA reference: 20293768
12. Revvity: Vanadis Extract Reaction Plates 45139 Model: 4306-0010 MHRA reference: 20341036
13. Smiths Medical: Medfusion syringe infusion pumps 45139 Model: 3500, 4000 MHRA reference: 21983249
14. Wom: Aquilex Fluid Control System 45108 Hysteroscopic irrigation/insufflation system Model: AQL-100PBS and AQL-100P MHRA reference: 8914228
15. Xiamen Compower Medical: Compower CP 2023-1_ Compower PVC Manual Resuscitator Model: YA-3#+M5 MHRA reference: 20540311

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) 

​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  

FAC406-015, 8B(i), Rev 6