Events

Rappel de Artis Dialysis System equipped with SW 8.15.06 and 8.33.02

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gambro 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-2015-RN-00057-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-22
  • 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-2015-RN-00057-1
  • 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
    Depending on the type of dialyzer membrane being used, excess foam may be generated in the venous circuit during patient connection and during the first few minutes of treatment. this specific condition is clearly visible to the operator.This issue was found to be primarily due to residual humidity in the fibers of the dialyzers with air permeable membranes. this problem has not been reported in dialyzers with non-air permeable membranes.None of the incidents reported resulted in a serious patient injury or medical intervention to preclude serious injury.
  • Action
    An Operator Manual Addendum is being prepared and expected to be released Q3 2015. In the interim the Customer Letter details the new instructions. This action has been closed-out on 18/07/2016.

Device

Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Modèle / numéro de série
    Artis Dialysis System equipped with SW 8.15.06 and 8.33.02ARTG Number: 141189
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd