Field Safety Notices (FSNs): 08/05/23 – 12/05/23

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

None

Section 2: medical devices 08/05/23 – 12/05/23

1. Abiomed: Impella 5.5 with SmartAssist heart pump 45033 Intracardiac Circulatory Assist Axial Pump Catheter Model: 0550-0007 MHRA reference: 5185967
2. B Braun: PROSET INFUSION SETs 45028 Intravenous Line Stopcock MHRA reference: 5154165
3. Brandon Medical: Quasar eLite 44984 Operating light & Operating light system MHRA reference: 5101386
4. Coloplast: Titan Inflatable Penile Prosthesis 44980 Inflatable Penile Prosthesis MHRA reference: 5096764
5. FH ORTHO: BEPOD 45036 MHRA reference: 5203538
6. FUJIFILM medwork: Dilatation balloon (DIL1-A1-Series) 44958 Model: DIL1-A1-06-40-23-35 MHRA reference: 5119405
7. Galt: Tearaway Introducer Set 45056 Vascular catheter introduction set non-implantable MHRA reference: 5224184
8. Helena Biosciences: Collagen 44995 Platelet aggregation study IVD, reagent Model: 5368, O863510 MHRA reference: 5114030
9. Immucor GTI Diagnostics: LIFECODES HLA-DQA1/B1 SSO Typing Kit – Customer Letter 45037 DNA-based tissue typing IVD, kit, NAT Model: 628930 MHRA reference: 5194585
10. Immucor GTI Diagnostics: LIFECODES HLA-DQA1/B1 SSO Typing Kit – Distributor Letter 45037 DNA-based tissue typing IVD, kit, NAT Model: 628930 MHRA reference: 5194587
11. Maxtec: Handi+ Oxygen Analyzer 45036 Analyzer, Gas, Oxygen Model: Handi+ ; Part No: R218P12-001 MHRA reference: 5229283
12. Medtronic: Shiley Adult FlexibleTracheostomy Tube 44986 Tracheostomy tube, non-reinforced, non-customized Model: 4CN65A, 4CN65R, 4UN65A, 4UN65R, 5CN70A, 5CN70R, 5UN70A, 5UN70R, 6CN75A, 6CN75R, 6UN75R, 7CN80A, 7CN80R, 7UN80A, 7UN80R, 8CN85A, 8CN85R, 8UN85A, 8UN85R, 9CN90R, 9UN90R, 10CN10R, 10UN10A, 10UN10R MHRA reference: 5145668
13. Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems – Viva™ and Brava Cardiac Resynchronization Therapy-Defibrillation (CRTD) Devices – Evera Implantable Cardioverter-Defibrillator (ICD) Devices – Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices – Visia AF and Visia AF MRI SureScan Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices – Primo MRI and Mirro MRI SureScan Implantable Cardioverter-Defibrillator (ICD) Devices – Claria MRI, Amplia MRI, Compia MRI CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology 45047 MHRA reference: 5231482
14. Randox: Specific Protein Control Levels 1-3 44887 Multiple clinical chemistry protein IVD, control MHRA reference: 5119933
15. Stago: STAR MAX, STA-R EVOLUTION, STA COMPACT/COMPACT MAX 44993 Laboratory coagulation analyser IVD, automated MHRA reference: 5099961
16. Stryker: METSTM Integral Shaft & Stem 45017 MHRA reference: 5230634

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