Events

Rappel de Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)

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-2016-RN-01290-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-30
  • 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-2016-RN-01290-1
  • 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
    An additional warning is to be included in the operator's manual with the advice that the arctic sun temperature management system is not to be used in the operating room environment. this is to address concerns regarding the potential for non-tuberculous mycobacterium (ntm) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. the probability of harm to a patient is considered remote.
  • Action
    Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment.

Device

Arctic Sun Temperature Management System (used for regulating the temperature and circulation of ...
  • Modèle / numéro de série
    Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)Arctic Sun 2000 Temperature Management System (230VAC)Product Code: 2000-03Arctic Sun 5000 Temperature Management System (220-240 V Australia)Product Code: 5000-01-03ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd