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Field Safety Notices (FSNs): 9 to 13 September 2023

IRICIncident Reporting &
Investigation Centre

Manufacturers’ Field Safety Notices

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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. None

Section 2: medical devices 9 to 13 September 2023

  1. Abbott: Afinion 2 19th May 2023 MHRA reference: 31845652   2023/009/004/601/050
  2. Agfa HealthCare NV: Enterprise Imaging XERO Viewer 45536 MHRA reference: 31859890    2024/009/009/601/019 
  3. Agilent: Please see comments (section 8) 26th June 2023 MLH2 antigen IVD; MSH6 antigen IVD; PMS2 IVD Model: GA08561-2, GA08661-2, GA08761-2 MHRA reference: 31848393    2023/007/004/601/015
  4. MHRA reference: 31848393    2023/007/004/601/015 (Acknowledgement) BALT EXTRUSION SAS: FARGO / CRISTAL BALLOON 26th July 2023 Model: FRG6F115_8MP / CBV18X40/110 MHRA reference: 31845020   2023/009/006/601/008
  5. Belmont Medical Technologies: Belmont Rapid Infuser, RI-2 1000 ml/min,750 ml/min 24th February 2024 Infusion pump, high-flow, warming Model: 903-00037A and 903-00039A MHRA reference: 31844932    2023/002/023/601/032
  6. Biocomposites Ltd: GeneX DS 2.5cc and GeneX DS 5cc 29th August 2023 MHRA reference: 31855155      2023/008/029/601/019 
  7. Biosense Webster: VARIPULSE™ Bi-Directional Catheter 26th April 2024 Cardiac irreversible electroporation system catheter MHRA reference: 31867911     2024/005/007/601/069
  8. Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD 13th September 2023 Single Chamber Implantable Defibrillator Model: Model A209 – A219 MHRA reference: 31844620    2023/009/013/601/067 
  9. Brandon Medical : Quasar eLite 27th February 2023 Operating light & Operating light system Model: Various MHRA reference: 31841136      2023/002/028/601/044
  10. CODAN ARGUS: ARGUS 717V 45536 General purpose infusion pump MHRA reference: 31808419     2024/008/026/601/016 MHRA reference: 31808419     2024/008/026/601/016 (Customer reply form)
  11. Emboflu: SQUID / SQUIDPERI 23rd July 2024 Embolization implant kit Model: See attachments MHRA reference: 31831954     2024/009/009/601/020
  12. Exmoor: Exmoor 20th March 2023 Intranasal splint, non-biodegradable Model: Nasal Splints MHRA reference: 31845706    2023/003/028/601/038
  13. Fresenius Medical Care: Stay safe Disinfection Cap 25th September 2023 Vascular catheter protective cap MHRA reference: 31856516    2023/010/002/601/040
  14. GE Healthcare: Centricity PACS System 6th September 2024 Picture archiving and communication system MHRA reference: 31814656    2024/009/006/601/054
  15. GE HealthCare: Centricity PACS; Centricity Universal Viewer 45200 MHRA reference: 31841514    2023/010/002/601/061
  16. Getinge: MAQUET ACROBAT-i Vacuum Stabilizer System 13th September 2023 ACROBAT-i Vacuum Stabilizer System Model: OM-10000Z MHRA reference: 31841801     2023/009/019/601/046 
  17. Getinge: MEERA operating table (see 8. Comments) 29th August 2024 Universal operating table, electrohydraulic Model: 720001B0; 720001B2; 720001F0; 720001F2; 710001B0; 710001B2; 700001B0; 700001F0 MHRA reference: 31876559   2024/009/011/601/067 (Customer letter) MHRA reference: 31876559   2024/009/011/601/067 (Reply form) 
  18. Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx 8th May 2024 Nucleic acid sequence analyser IVD, NGS MHRA reference: 31814691    2024/005/006/601/079
  19. Implantcast: IFU / OPT: MUTARS® RS stems and extension pieces 13th May 2024 Model: 09300015, MURSSTxx, 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515 MHRA reference: 31831899    2024/005/016/601/010
  20. JRI Orthopaedics Limited: Evolution Rasps 23rd August 2024 MHRA reference: 31815462    2024/008/027/601/014
  21. Löwenstein Medical: LUISA, TIVAN LS, Life One (LM150TD) series 45047 MHRA reference: 31846819    2023/009/004/601/013
  22. Masimo: TC-I Reusable Tip Clip Sensor 45078 Model: 1895, 2503, and 4053 MHRA reference: 31841425   
  23. Medex: Qitexio – 20ml Luer Lock Syringe 28th February 2023 General purpose syringe, single-use MHRA reference: 31846792    2023/009/005/601/044 
  24. Medicina: Medicina ENFit enteral, single use & reusable oral 15th June 2022 Model: LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH05 MHRA reference: 31843630    2023/006/022/601/044 
  25. Medline: Hudson RCI® AQUAPAK® Humidifier Adaptors FSN 23-08 Hudson RCI® AQUAPAK® Humidifier Adaptors Model: < Add model (normal style)> MHRA reference: 31841420     2023/008/031/601/077
  26. Medtronic: Hugo™ RAS Arm Cart Assembly Hugo™ RAS Tower 45139 MHRA reference: 31841489      2023/008/029/601/068
  27. Merit Medical: MONARCH® Inflation 23rd August 2024 MHRA reference: 31814402    2024/009/004/601/031
  28. Nouvag: Control unit Dispenser DP 30 3rd July 2024 Bedside infusion pump, single-channel  Model: 4180, 4187 MHRA reference: 31839942      2023/009/008/601/055
  29. One Lambda: C1qScreen 7th September 2023 HLA class I & II antibody screening IVD, kit, MHRA reference: 31844724   2023/010/002/601/067
  30. Oxylitre Holdings Limited: Standard Pressure Regulators 45139 Non-fixed medical gas cylinder regulator Model: R16 Series MHRA reference: 31840218     2023/008/031/601/035
  31. Permobil: Smartdrive MX2+with Pushtracker E2/E3 5th May 2023 Wheelchair electric-motor-driven propulsion system Model: MX2+ MHRA reference: 31845530     2023/005/008/601/045
  32. Philips: Evolution Upgrade 3.0T, Ingenia 1.5T, Ingenia 3.0T 23rd August 2024 Magnetic Resonance Imaging (MRI) unit Model: 781260, 781270, 781358, 781359, 782101, 782103, 782105, 782106, 782107, 782108, 782109, 782110, 782112, 782113, 782115, 782117, 782118, 782119, 782120, 782129, 782133, 782136, 782140, 782143, 782150, 782151 MHRA reference: 31855156     2024/009/002/601/046
  33. Promedics: Promedics 22nd August 2023 Wrist and hand orthosis Model: WTE MHRA reference: 31839987       2023/008/025/601/037
  34. Reison Medical: Tube Holder CC-23-014 Model: 10-611 MHRA reference: 31841374    2023/009/004/601/022 
  35. Roche: Please see tables in comments section. SB_RDC_2023_02 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENT MHRA reference: 31841104 MHRA reference: 31841104 MHRA reference: 31841104           
  36. Siemens Healthcare: Atellica DCA Analyzer and ACR Reagent Kit 44986 See general comments – GMDN 56680 and GMDN 62751 MHRA reference: 31842976    2023/003/016/601/002 MHRA reference: 31842976    2023/003/016/601/002 (letter)
  37. Siemens Healthineers: Atellica DCA Analyzer and ACR Reagent Kit 44986 See general comments MHRA reference: 31854788    2023/003/016/601/002
  38. SLE Ltd: SLE6000 Infant Ventilator 24th June 2024 SLE6000 ventilator Model: SLE6000 MHRA reference: 31844091     2024/006/014/601/058 
  39. Smiths Medical: Portex™ Blue Line Siliconised PVC Tracheotomy Tube 9th September 2024 Tracheostomy tube, non-reinforced, non-customized Model: See FSN MHRA reference: 31842702     2024/004/011/601/037
  40. Terumo: Spectra Optia Apheresis System  45444 MHRA reference: 31833460     2024/006/006/601/049
  41. Tosoh Europe: AIA-PACK MULTI ANALYTE CONTROL 5th September 2023 MHRA reference: 31842892      2023/009/001/601/029
  42. Vygon: DOLPHIN inflation device 5th September 2023 Catheter-balloon inflator, single-use MHRA reference: 31859864    2023/009/007/601/049
  43. Werfen: ACL TOP 700/750-CTS-LAS /300/350/500/550 CTS 970CL 45139 Model: ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750 LAS, ACL TOP 550 CTS, ACL TOP 350 CTS MHRA reference: 31842340  
  44. Werfen: ACL TOP 700/750-CTS-LAS /300/350/500/550 CTS 970CL 45149 Coagulation analyser IVD, laboratory MHRA reference: 31842691    2021/010/022/701/067
  45. ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm 22nd September 2023 MHRA reference: 31844718     2023/009/022/601/022

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. 

Section 3: updates and changes to previously published medical device FSNs

Page summaryChange(s) made
n/an/a

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  

FAC406-212, 8B(i), Rev 7

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IHEEM

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