Events

Rappel de Arcomed Volumed µVP7000 Infusion Pump

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Admedus Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00314-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00314-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Arcomed Volumed µVP7000 Infusion PumpARTG Number: 279584(Admedus Australia - Infusion pump, general-purpose)
  • Manufacturer
    Admedus Australia Pty Ltd

Manufacturer

Admedus Australia Pty Ltd