Events

Safety Alert Or Field Safety Notices for Aquarius haemofiltration machines

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Edwards Lifesciences Ltd, supplied by Baxter Healthcare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2010/039
  • Date
    2010-05-12
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-aquarius-haemofiltration-machines-follow-instructions-carefully
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    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)
  • Reason
    (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).
  • 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’.

Device

Aquarius haemofiltration machines
  • Model / Serial
  • Product Description
    All Aquarius haemofiltration machines.Manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare.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.
  • Manufacturer
    Edwards Lifesciences Ltd, supplied by Baxter Healthcare

Manufacturer

Edwards Lifesciences Ltd, supplied by Baxter Healthcare
  • Manufacturer Address
    Edwards Lifesciences Andleeb Arshad Sherwood House 78-84 London Road Newbury Berkshire RG14 1LA Tel: 0870 606 2040 Fax: 0870 606 2050Email: andleeb_arshad@edwards.com
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    MHRA