Events

Rappel de Prismaflex Control Units

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-2018-RN-00366-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-16
  • 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-00366-1
  • 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 will be installing new firmware on all prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. the failure mode may result in a “voltage out of range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. this failure mode can occur at any time during treatment or outside of treatment. to date, there have been no reports of serious injury associated with this issue.
  • Action
    Baxter advises that a service representative will be in contact with customers to schedule the firmware upgrade to rectify this issue. Until the firmware has been installed, users may continue to use the units that have not exhibited the "Voltage Out of Range" malfunction alarm.

Device

Prismaflex Control Units
  • Modèle / numéro de série
    Prismaflex Control Units Product Codes: 955052, 114870, 114489, 107493, 113082, 113874All serial numbers of the above product are affectedARTG Number: 142047(Baxter Healthcare - Prismaflex - Therapeutic plasma exchange system)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd