Events

Rappel de Aquarius GEF08200 Device, V4 Software

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-2013-RN-00626-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-25
  • 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-2013-RN-00626-1
  • 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
    Baxter is recalling this device due to the ability to override the total fluid balance alarm which could potentially lead to hypovolaemia or hypervolaemia. a software update was initially proposed to correct the issue for models gef08200 and gef09600, however as the software update was found to incompatible with model gef08200, baxter determined that there was no permanent solution available for this model.
  • Action
    Hospitals are requested to provide Baxter with details of the units remaining in use. On receipt of this notification Baxter will organise for the recovery of the device. The Aquarius GEF08200 with V4 software can continue to be used until replacement devices are sourced provided the work around identified in the device Warning Label is followed. The warning label contains the following information: WARNING Repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. Beware this can cause serious patient injury. You need to identify the cause of the alarm and correct the fluid rate if necessary.

Device

Aquarius GEF08200 Device, V4 Software

Manufacturer

Baxter Healthcare Pty Ltd