Medical Device Alert: All Aquarius haemofiltration machines manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare (MDA/2010/039)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/039 or 2010/003/011/291/021.

Technical aspects
Roopa Prabhakar or Catriona Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3293/3219
Fax: 020 7084 3209

Email: roopa.prabhakar@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

Reports have been received of the wheels breaking due to wear or improper use. There is a risk of the machine toppling or falling over, which can cause injury and therapy interruption.

Damage to the wheels (which are referred to in the attached technical bulletin as ‘rollers’) may not have been detected during routine servicing, so it is essential to check them regularly. If the wheels are damaged, the machine should be taken out of service and repaired.

Appendix to MDA/2010/039 - Edwards Lifesciences: Technical bulletin (74Kb)

Users should ensure that machines are transported in accordance with the instructions in the operating manual.

Maintenance staff should ensure that:

• they are aware of the recent technical bulletin (see appendix), which describes specific wheel inspections
• all wheels are inspected for wear and/or damage and appropriate action is taken, as required.

Users should refer to the instructions in the operating manual in order to minimise damage to the machine’s wheels, which is most likely to be caused by movement of the machine over steps, stairs or other uneven surfaces. The instructions state:
‘To move or transport the Aquarius it is necessary to release the locking tabs on the wheels. The Aquarius can then be rotated and freely moved about. To move the Aquarius over steps or stairs the locking tabs must be released. The system should be tilted, lifted, and carried by at least three people. The Aquarius must not be pushed over uneven floors’.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• anaesthetists
• biomedical engineering staff
• health and safety managers
• intensive care nursing staff (adult)
• intensive care nursing staff (paediatric)
• intensive care physicians
• intensive care units (adult and paediatric)
• intensive care, directors of
• medical directors
• nursing executive directors
• renal technicians
• risk managers
• theatre managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• hospitals in the independent sector

Manufacturer
Edwards Lifesciences
Andleeb Arshad
Sherwood House
78-84 London Road
Newbury
Berkshire
RG14 1LA

Tel: 0870 606 2040
Fax: 0870 606 2050

Email: andleeb_arshad@edwards.com

Supplier
Baxter Healthcare
Surecall
Wallingford Road
Compton
Newbury
Berkshire
RG20 7QW

Tel: 01635 206 345

Email: surecall@baxter.com