Events

Recall of Arcomed Volumed µVP7000 Infusion Pump

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Admedus Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00314-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00314-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, arcomed ag, has been informed that in some rare cases the volumed µvp7000 did not perform within the specified volumetric accuracy with pvc lines due to low door pressure. a deviation of the infused volume can have a negative impact on the patient. the pumps do perform an initial stop flow test that also tests the door pressure, however in rare occasions pumps would still not perform within the specified tolerances after passing the stop flow test. admedus australia, following consultation with the manufacturer, have developed a 'strip test" to be included in the standard preventative maintenance testing procedures, which are used to check that the machines are operating in accordance with specifications. the strip test will check devices for mechanical tolerances of the door which will increase the safety tolerances of the device.
  • Action
    Admedus is advising customers to add the replacement page provided with the Customer Letter to the user manual of the device. Users should continue to monitor operation of the pumps and arrange for the pump to be checked by a trained service engineer if they notice any volumetric inaccuracies (note: small deviations within the specifications (5%) may occur). Service Technicians are being provided a replacement page for the service manual instructing how to perform the 'Strip Test'.

Device

Arcomed Volumed µVP7000 Infusion Pump
  • Model / Serial
    Arcomed Volumed µVP7000 Infusion PumpARTG Number: 279584(Admedus Australia - Infusion pump, general-purpose)
  • Manufacturer
    Admedus Australia Pty Ltd

Manufacturer

Admedus Australia Pty Ltd