Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia.

Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia

Action

For all healthcare staff

  • When using the Ultrafilter U9000, be aware of the potential for fluid leakage to occur from the cap of the Ultrafilter, particularly when high risk patients are being treated.
  • Be vigilant when using the AK96 or AK 98v1 be aware of the potential for undetected leaks from the Ultrafilter cap.
  • Be aware of the updated advice on maximum lifetime usage in the manufacturer’s Field Safety Notice
  • Ensure home patients are aware of the risk that fluid leakage may occur and they are informed on how to safely manage any leaks.

For all technical staff

  • Check current machines using the Ultrafilter to see whether they require replacing as per the updated maximum usage criteria listed in the manufacturer’s Field Safety Notice
  • Update processes for replacing Ultrafilters in line with manufacturer’s updated guidance, until counter maximum is corrected at next manufacturer service.
  • Ensure counter maximum is corrected at next manufacturer service

Action by

Renal nurses, renal technicians and staff supporting patients receiving haemodialysis at home

Deadlines for actions

Actions underway: 13 June 2018 Actions complete: 08 August 2018

Medical Device Safety Officers (in England)

Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA

Problem / background

Baxter Healthcare has updated the maximum usage lifetime of the Ultrafilter U9000 to reduce the occurrence of leaks. This applies when the Ultrafilter is used with the AK96 and AK98 v1 machines. The lifespan remains unchanged if the Ultrafilter is used with AK98 v2 and Artis machines as they have a leak detector sensor. The updated advice is listed in the manufacturer’s Field Safety Notice.

Manufacturer contacts

Baxter Healthcare

Tel: 01604704603 Email: uk_shs_fca@baxter.com

Distribution

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • Adult intensive care units
  • Biomedical engineering staff
  • Equipment stores
  • Equipment libraries and stores
  • Haemodialysis nurses
  • Haemodialysis units
  • Health and safety managers
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Nursing executive directors
  • Paediatric intensive care units
  • Paediatric wards
  • Renal medicine departments
  • Renal medicine, directors of
  • Risk managers
  • Special care baby units
  • Staff supporting patients receiving haemodialysis at home

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2018/015 or [2018/003/013/478/002].

Technical aspects

Roopa Prabhakar or Emma Rooke, MHRA

Tel: 020 3080 6461 or 7205

Email: Roopa.Prabhakar@mhra.gov.uk or emma.rooke@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: DCT@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NICAS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Fax: 0131 314 0722

Email: nss.iric@nhs.net

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2018/015 - 2018/003/013/478/002

Published 16 May 2018