Events

Rappel de Bard Arctic Sun 5000 Temperature Management 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 Bard 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-2015-RN-01116-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-17
  • 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-01116-1
  • 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
    Bard medical division (bmd) has identified that the arctic sun 5000 temperature management system with certain serial numbers may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery. the exhausted battery will prevent the arctic sun temperature management system control panel from launching software and initiating operation. this presents a potentially serious issue since the system is used to control patient temperatures within a pre-set range and has the potential of not being available to provide therapy when needed.The issue identified however does not affect an arctic sun 5000 once it is successfully powered up since the batteries are no long being called upon and the unit is operating on mains power.
  • Action
    The sponsor is advising the user that if the device is currently in clinical use, it can continue to be used without concern for this failure. The battery drainage issue only occurs when the unit is off and in stand-by mode. The sponsor will arrange for a technician to come to the user's facility for the evaluation and potential replacement of the affected electronic components. This action has been closed-out on 26/08/2016.

Device

Bard Arctic Sun 5000 Temperature Management System
  • Modèle / numéro de série
    Bard Arctic Sun 5000 Temperature Management System Serial numbers: 1255, 2325, 2515, 2530, 2643, 2650, 2722, 2755, 2780, 2781, 5157, 5178, 5181, 5240, 5374, 5459, 5461, 5232. ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd