Search
© IHEEM 2024. All rights reserved.

Field Safety Notices (FSNs): 30/09/24 – 04/10/24 – UPDATE

IRICIncident Reporting &
Investigation Centre

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

Field Safety Notices: 30 September to 4 October 2024 – UPDATE

We have become aware that MHRA may have experienced a similar technical problem to the one that affected their FSN webpage a few weeks ago. The webpage affected on this occasion is Field Safety Notices: 30 September to 4 October 2024.

As you know, our weekly list of FSNs is copied from the MHRA webpage. Of the 26 FSNs that were listed on our weekly email (below), 20 have subsequently been removed from the MHRA webpage, six FSNs remain on it and one FSN has been added. This means that instead of 26 there are now only seven FSNs on the webpage as follows:  

  1. Trinity Biotech: Premier Hb9210 HbA1c Analyzer 45565 Product Code: 42790 Model: Refer to FSN MHRA reference: 32787346   2024/009/030/601/081
  2. Smiths Medical: Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, Thermovent™ 1200 45568 Model: Refer to FSN MHRA reference: 32773880   2024/009/030/601/011
  3. Boston Scientific: Model L331 ACCOLADE™, L231 PROPONENT™, and L131 ESSENTIO™ DR EL pacemakers 45547 Pacemakers Model: Refer to FSN MHRA reference: 32773671   2024/009/020/601/083
  4. Baxter: PST 500 U Precision Surgical Table 45475 Universal operating table, electromechanical Model: 4080100 MHRA reference: 32795725   2024/007/002/601/080
  5. Siemens Healthineers: IMMULITE 2000 and IMMULITE 2000 XPi Analyzer 45536 Lot Number: 438, 439, 440 MHRA reference: 32802893   2024/010/001/601/085
  6. Drägerwerk AG: Atlan Family 45566 Atlan anaesthesia workstations Model: Refer to FSN MHRA reference: 32802744   2024/010/002/601/022
  7. Philips: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 Flow Sensor Nebulized Aerosol Deposition 45554 Portable Electric Ventilator Model: Please refer to Units Affected List MHRA reference: 32836344   2024/009/020/601/069

Of the 20 that have been removed, seventeen previously appeared on the MHRA webpage Field Safety Notices: 26 February to 1 March 2024. We recommend you ignore these as you would have assessed them at the time. However, the following three FSNs appear to be included on the list but this is not confirmed by the associated reference numbers and we therefore recommend you process them using your normal procedures as though they were new:

  1. Medicina: ENFit double-lumen polyurethane “Replogle” tube  45334 Model: NF02L MHRA reference: 28030507   
  2. RaySearch Laboratories: RayStation 45345 Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A MHRA reference: 28043273    
  3. Siemens Healthineers: ACUSON Juniper and ACUSON Juniper Select Ultrasound systems 45330 General-purpose ultrasound imaging system Model: 11335791, 11653093 (System IVK: 11335791) MHRA reference: 32819130   2024/002/027/601/057 

We have highlighted this to MHRA.

Kind regards

Innes Connor

IRIC Manager

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 6162 | innes.connor@nhs.scot | Chat with me on Teams 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

From: nss iric <nss.iric@nhs.scot>
Sent: Tuesday, October 8, 2024 4:49 PM
Subject: Field Safety Notices (FSNs): 30/09/24 – 04/10/24

IRICIncident Reporting &
Investigation Centre

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

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 30/09/24 – 04/10/24

.

1.  Product Recall: Wurth Stretch X Electric SB P E FO WRU Safety Shoe (2408-0116)

2.     Product Recall: Venicci Engo Car Seat (2404-0105) updated

Reissued links from w/b 16/09/24

  1. Product Safety Alert: Water Beads (PSA7)
  2. Product Recall: ISEO F6 Extra/R700 European Cylinder Locks (Thumbturn Versions) (2406-0041)
  3. Product Recall: 3M Peltor X4A Noise Cancelling Headphones (2409-0022)
  4. Product Recall: Pro Breeze 2L Air Fryer 1000W with Digital Display sold via Amazon and Probreeze.com (2409-0044)
  5. Product Recall: Pifco 2KW Convector Heater with Turbo and Timer sold by Home Bargains (2409-0045)
  6. Product Recall: Taf Toys Savannah & Urban Garden Foam Playmats (2409-0034)
  7. Product Recall: Weasel and the Whale Dummy Clip – Liberty Print Fabric sold via Etsy (2404-0155)
  8. Product Recall: My Babiie Infant Carriers (2409-0014)

Section 2: medical devices 30/09/24 – 04/10/24

  1. Siemens Healthineers: ACUSON Juniper and ACUSON Juniper Select Ultrasound systems 45330 General-purpose ultrasound imaging system Model: 11335791, 11653093 (System IVK: 11335791) MHRA reference: 32819130   2024/002/027/601/057 
  2. Aidence: Veye Lung Nodules 45349 Model: 3.22.0 MHRA reference: 28038186   
  3. Arjo: IndiGo Intuitive Drive Assistance 45336 Accessory for basic electric hospital beds Model: INDI-XXX MHRA reference: 28028412   
  4. Baxter: Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette 45351 Surgical intravascular shunt  MHRA reference: 28043281 Letter    MHRA reference: 28043281 FSN     
  5. BD: BodyGuard MicroSet 45348 Electric infusion pump admin set,single use  MHRA reference: 28028023    
  6. Beckman Coulter: DxA Automation System / DxA Aliquoter 23 February 2024 FSN-24006 Specimen processing instrument IVD, automated  MHRA reference: 28043275   
  7. Beckman Coulter: Access Substrate 45345 Chemiluminescent substrate reagent IVD Model: 81906 MHRA reference: 28043269   
  8. bioMérieux: BIOFIRE Pneumoniaplus (PNplus) Panel   45330 Multiple-type respiratory pathogen nucleic acid  Model: RFIT-ASY-0142 (PNplus, 30-pack), RFIT-ASY-0143 (PNplus, 6-pack)  MHRA reference: 27943715   
  9. bioMérieux: MUELLER HINTON E AGAR 44952 Mueller-Hinton agar antimicrobial susceptibility  MHRA reference: 27942675    
  10. BVI: 581012 – IRRIGATION HANDLE (20/SP) 45335 MHRA reference: 28029327   
  11. CONMED: HIP PRESERVATION SYSTEM SIGNATURE SERIES 45331 Arthroscopic shaver system blade, single-use MHRA reference: 28043125   
  12. Cook: Dilators – Coons Taper, EntuitSecure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy Needles 45350 Model: JCD22.0-38-20-COONS, GIAS-SRM-ADJ-2, DCHN-22-15.0, DCHN-22-15.0-U MHRA reference: 28028797   
  13. LINK: OptiStem, Rasp Handle Stainless Steel 45349 Model: 17-5220/01 MHRA reference: 28040570    
  14. Luminex: NxTAG Respiratory Pathogen Panel  45316 MHRA reference: 28038177 Letter     MHRA reference: 28038177 FSN   
  15. Medicina: ENFit double-lumen polyurethane “Replogle” tube  45334 Model: NF02L MHRA reference: 28030507   
  16. Olympus: SOLTIVE SuperPulsed Laser System   45350 General/multiple surgical solid-state laser system Model: TFL-PLS, TFL-SLS MHRA reference: 28029779   
  17. Randox: MICROALBUMIN CALIBRATOR SERIES (mALB CAL)   45322 Microalbumin IVD, calibrator MHRA reference: 28028402   
  18. RaySearch Laboratories: RayStation 45345 Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A MHRA reference: 28043273    
  19. Roche: t 511/ t 711: PT-aPTT 45017 MHRA reference: 27919638 
  20. Siemens Healthineers: ACUSON Redwood ultrasound system  Ref: US005-24-S + US011-12-24-S  General-purpose ultrasound imaging system  Model: 11503314   MHRA reference: 28037799
  21. Trinity Biotech: Premier Hb9210 HbA1c Analyzer 45565 Product Code: 42790 Model: Refer to FSN MHRA reference: 32787346   2024/009/030/601/081
  22. Smiths Medical: Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, Thermovent™ 1200 45568 Model: Refer to FSN MHRA reference: 32773880   2024/009/030/601/011
  23. Boston Scientific: Model L331 ACCOLADE™, L231 PROPONENT™, and L131 ESSENTIO™ DR EL pacemakers 45547 Pacemakers Model: Refer to FSN MHRA reference: 32773671   2024/009/020/601/083
  24. Baxter: PST 500 U Precision Surgical Table 45475 Universal operating table, electromechanical Model: 4080100 MHRA reference: 32795725   2024/007/002/601/080
  25. Siemens Healthineers: IMMULITE 2000 and IMMULITE 2000 XPi Analyzer 45536 Lot Number: 438, 439, 440 MHRA reference: 32802893   2024/010/001/601/085
  26. Drägerwerk AG: Atlan Family 45566 Atlan anaesthesia workstations Model: Refer to FSN MHRA reference: 32802744   2024/010/002/601/022

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/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

 

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 in our NSS Strategic Framework 2024-2026

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

——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.

——————————————————————————————————————————————————–

You need to be a member and logged in to see this content.

IHEEM

Institute of Healthcare Engineering and Estate Management,
2 Abingdon House,
Cumberland Business Centre Northumberland Road,
Portsmouth Hants,
PO5 1DS

Sign up to hear from us