Field Safety Notices (FSNs): 9 to 13 September 2024

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General List

Dear all

Further to yesterday’s email which listed 45 medical device FSNs. As you know the list is copied from source which is an MHRA webpage. However, we are aware that today there are only 29 FSNs listed on the MHRA webpage as follows:

1. Abbott: Afinion 2 45065 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) 45103 MLH2 antigen IVD; MSH6 antigen IVD; PMS2 IVD Model: GA08561-2, GA08661-2, GA08761-2 MHRA reference: 31848393    2023/007/004/601/015 MHRA reference: 31848393    2023/007/004/601/015 (Acknowledgement)
4. Biosense Webster: VARIPULSE™ Bi-Directional Catheter 45408 Cardiac irreversible electroporation system catheter MHRA reference: 31867911     2024/005/007/601/069
5. Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD 45182 Single Chamber Implantable Defibrillator Model: Model A209 – A219 MHRA reference: 31844620    2023/009/013/601/067 
6. 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)
7. Emboflu: SQUID / SQUIDPERI 45496 Embolization implant kit Model: See attachments MHRA reference: 31831954     2024/009/009/601/020
8. GE Healthcare: Centricity PACS System 45541 Picture archiving and communication system MHRA reference: 31814656    2024/009/006/601/054
9. GE HealthCare: Centricity PACS; Centricity Universal Viewer 45200 MHRA reference: 31841514    2023/010/002/601/061
10. Getinge: MAQUET ACROBAT-i Vacuum Stabilizer System 45182 ACROBAT-i Vacuum Stabilizer System Model: OM-10000Z MHRA reference: 31841801     2023/009/019/601/046 
11. Getinge: MEERA operating table (see 8. Comments) 45533 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) 
12. Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx 45420 Nucleic acid sequence analyser IVD, NGS MHRA reference: 31814691    2024/005/006/601/079
13. Implantcast: IFU / OPT: MUTARS® RS stems and extension pieces 45425 Model: 09300015, MURSSTxx, 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515 MHRA reference: 31831899    2024/005/016/601/010
14. JRI Orthopaedics Limited: Evolution Rasps 45527 MHRA reference: 31815462    2024/008/027/601/014
15. Merit Medical: MONARCH® Inflation 45527 MHRA reference: 31814402    2024/009/004/601/031
16. Oxylitre Holdings Limited: Standard Pressure Regulators 45139 Non-fixed medical gas cylinder regulator Model: R16 Series MHRA reference: 31840218     2023/008/031/601/035
17. Permobil: Smartdrive MX2+with Pushtracker E2/E3 45051 Wheelchair electric-motor-driven propulsion system Model: MX2+ MHRA reference: 31845530     2023/005/008/601/045
18. Philips: Evolution Upgrade 3.0T, Ingenia 1.5T, Ingenia 3.0T 45527 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
19. Reison Medical: Tube Holder CC-23-014 Model: 10-611 MHRA reference: 31841374 2023/009/004/601/022     
20. 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)
21. Siemens Healthineers: Atellica DCA Analyzer and ACR Reagent Kit 44986 See general comments MHRA reference: 31854788    2023/003/016/601/002
22. SLE Ltd: SLE6000 Infant Ventilator 45467 SLE6000 ventilator Model: SLE6000 MHRA reference: 31844091     2024/006/014/601/058 
23. Smiths Medical: Portex™ Blue Line Siliconised PVC Tracheotomy Tube 45544 Tracheostomy tube, non-reinforced, non-customized Model: See FSN MHRA reference: 31842702     2024/004/011/601/037
24. Terumo: Spectra Optia Apheresis System  45444 MHRA reference: 31833460     2024/006/006/601/049
25. Tosoh Europe: AIA-PACK MULTI ANALYTE CONTROL 45174 MHRA reference: 31842892      2023/009/001/601/029
26. Vygon: DOLPHIN inflation device 45174 Catheter-balloon inflator, single-use MHRA reference: 31859864    2023/009/007/601/049
27. 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  
28. 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
29. ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm 45191 MHRA reference: 31844718     2023/009/022/601/022

The list we emailed yesterday included the following 16 FSNs but they do not appear on the MHRA webpage today:

1. BALT EXTRUSION SAS: FARGO / CRISTAL BALLOON 26th July 2023 Model: FRG6F115_8MP / CBV18X40/110 MHRA reference: 31845020   2023/009/006/601/008
2. 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
3. Biocomposites Ltd: GeneX DS 2.5cc and GeneX DS 5cc 29th August 2023 MHRA reference: 31855155      2023/008/029/601/019 
4. Brandon Medical : Quasar eLite 27th February 2023 Operating light & Operating light system Model: Various MHRA reference: 31841136      2023/002/028/601/044
5. Exmoor: Exmoor 20th March 2023 Intranasal splint, non-biodegradable Model: Nasal Splints MHRA reference: 31845706    2023/003/028/601/038
6. Fresenius Medical Care: Stay safe Disinfection Cap 25th September 2023 Vascular catheter protective cap MHRA reference: 31856516    2023/010/002/601/040
7. Löwenstein Medical: LUISA, TIVAN LS, Life One (LM150TD) series 45047 MHRA reference: 31846819    2023/009/004/601/013
8. Masimo: TC-I Reusable Tip Clip Sensor 45078 Model: 1895, 2503, and 4053 MHRA reference: 31841425   
9. Medex: Qitexio – 20ml Luer Lock Syringe 28th February 2023 General purpose syringe, single-use MHRA reference: 31846792    2023/009/005/601/044 
10. 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 
11. 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
12. Medtronic: Hugo™ RAS Arm Cart Assembly Hugo™ RAS Tower 45139 MHRA reference: 31841489      2023/008/029/601/068
13. 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
14. One Lambda: C1qScreen 7th September 2023 HLA class I & II antibody screening IVD, kit, MHRA reference: 31844724   2023/010/002/601/067
15. Promedics: Promedics 22nd August 2023 Wrist and hand orthosis Model: WTE MHRA reference: 31839987       2023/008/025/601/037
16. 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           

We haven’t yet established how the additional 16 FSNs came to be in the list that we emailed yesterday or how the date range text in the email subject line (which is normally copy/paste from the webpage) stated 9 to 13 September 2023 instead of 9 to 13 September 2024. It’s possible the page has been amended and the issue date of 17 September and publication date of 19 September suggests this may have happened.  However, we have raised a query with MHRA and we are also looking for possible explanations within our own process. In the meantime, based on limited checks, the additional 16 FSNs appear to be historical but possibly not previously posted on the MHRA website. In addition there is no indication they have been duplicated from a previous list(s). We therefore recommend you process the additional 16 FSNs as you normally do and we’ll provide further information as it becomes available.

Kind regards

Innes Connor