Field Safety Notices (FSNs): 24/07/23 – 28/07/23

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: Nabaiji Baby Inflatable Float with Built-in Harness sold by Decathlon (2307-0028)

Section 2: medical devices 24/07/23 – 28/07/23

1. Abbott: FreeStyle LibreLink App 45122 Invasive Interstitial-fluid glucose monitoring system MHRA reference: 5410313
2. Abbott: FreeStyle LibreLink App 45124 Invasive Interstitial-fluid glucose monitoring system MHRA reference:5396820
3. Abbott: Proclaim, Infinity 45108 Spinal Cord-, Deep Brain electr. stimulation sys. Model: 3660, 3662, 3664, 6660, 6662 MHRA reference: 5388216
4. B Braun: 2 piece syringes 45131 Metered-delivery hypodermic syringe MHRA reference: 5396828
5. Draeger: HME TwinStar Plus and corresponding sets 45108 Heat/moisture exchanger/microbial med. gas filter MHRA reference: 5394600
6. ICU Medical: Plum 360 infusion systems 45126 MHRA reference: 5388210
7. Philips: Trilogy Evo O2 Trilogy EV300 44986 MHRA reference: 5394628
8. Philips: 3D9-3v Transducer 45106 Ultrasound system, Imaging, General Purpose Model: 3D9-3v MHRA reference: 5395815
9. SCIEX: 4500MD LC-MS/MS System and Citrine LC-MS/MS System 45128 MHRA reference: 5396894
10. Siemens Healthineers: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein 45108 Total protein IVD, kit, enzyme spectrophotometry MHRA reference: 5396889
11. Siemens Healthineers: ACUSON Redwood ultrasound system US006/23/S General-purpose ultrasound imaging system Model: 11503314 MHRA reference: 5394888
12. Smith & Nephew: SECURA No-Sting Skin-Prep/Barrier Film 45113 Synthetic polymer liquid barrier dressing, sterile MHRA reference: 5396907
13. TIB Molbiol: LightMix ModularDx Sapovirus 44994 MHRA reference: 5395898

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 

​Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts

​  

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