Events

Rappel de Prismaflex Control Unit (with software versions prior to 8.10)

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-00385-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-26
  • 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-00385-1
  • 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 has received reports of device operators failing to adhere to the instructions for use (ifu) pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome.
  • Action
    Baxter will be installing a free software upgrade at the users' facility. In the interim, Baxter is advising users that they may continue to use the affected units by following the instructions provided in the Prismaflex Operator’s Manual and the on-screen instructions when unloading the disposable set. Specifically, users should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading.

Device

Prismaflex Control Unit (with software versions prior to 8.10)
  • Modèle / numéro de série
    Prismaflex Control Unit (with software versions prior to 8.10)Prismaflex 4.11Product Code: 113082Prismaflex 6.10 ROWProduct Code: 114489Prismaflex 7.XX ROWProduct Code: 114870All Serial NumbersARTG Number: 142047
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd