Events

Rappel de Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I

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-2017-RN-00494-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • 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-2017-RN-00494-1
  • 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 healthcare is issuing a device correction for specific models of the artis dialysis systems in order to update the current software versions to the new software versions. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as detailed in the operator’s manual. users of these devices should adhere to the instructions provided in the current operator’s manual for addressing alarm #642.
  • Action
    Clinicians may continue to safely use the affected Artis dialysis systems provided they utilise additional vigilance to adhere to the instruction for use for addressing Alarm #642, as documented in the Operator’s Manual until the software correction can be provided to the relevant facilities.

Device

Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I
  • Modèle / numéro de série
    Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio IProduct Codes: 110635, 115323 and 115147All Serial NumbersARTG Number: 141189
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd