Events

Rappel de SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-01528-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-19
  • 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-01528-1
  • 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
    Syncardia has updated the freedom driver system manuals and labelling to strengthen existing labelling content with regard to freedom driver drops, rough handling and exposure to liquid/debris. the freedom driver system manuals have been updated as follows: - advising patients to switch from their primary freedom driver to their backup freedom driver in the event their freedom driver is dropped, subjected to rough handling or exposed to liquid/debris. - adding more detailed information regarding the definition of rough handling. - advising hospital clinicians, patients and their caregivers to clean the freedom driver and drivelines only with a cloth lightly dampened with water. - advising hospital clinicians to refresh patient and caregiver training at every clinic visit.
  • Action
    Device Technologies is providing users with updated manuals.

Device

SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart Sy...
  • Modèle / numéro de série
    SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd