Aquarius haemofiltration machines - follow instructions carefully
(Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (MDA/2010/039)
Device
All Aquarius haemofiltration machines.
Manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare.
An image of an Aquarius haemofiltration machine.
Aquarius haemofiltration machines used to be manufactured and badged by Edwards Lifesciences. However, Baxter Healthcare took over responsibility for the supply and servicing of Aquarius Haemofiltration Devices in September 2009, following their acquisition of the Edwards Haemofiltration business.
Problem
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.
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Action
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’.
Distribution
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 contact
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
Feedback
If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
Appendix
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England
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 .
Northern Ireland
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)
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website .
Further information about SABS can be found on the SABS 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
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 .
Wales
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
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