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
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.
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
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/015 or [2018/003/013/478/002].
Roopa Prabhakar or Emma Rooke, MHRA
Tel: 020 3080 6461 or 7205
Email: Roopa.Prabhakar@mhra.gov.uk or email@example.com
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
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
Please report directly to NIAIC using the forms on our website.
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
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).