Events

Rappel de Animas Insulin Infusion Pump (ambulatory insulin infusion pump)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Australasian Medical & Scientific 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-2012-RN-00690-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-07-20
  • 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-2012-RN-00690-3
  • 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
    Some patients experienced gradual wear of their insulin pump keypad that led to damage such as tearing or peeling of the edge of the keypad from the insulin infusion pump. the buttons may not respond as intended. the potential hazard is that it may cause the pump to malfunction and may cause under infusion or over infusion of insulin, resulting in hyperglycaemia or hypoglycaemia respectively.
  • Action
    Customers are requested to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of inspecting the pump. The Sponsor will replace any pumps that have a confirmed issue with the keypad.

Device

Animas Insulin Infusion Pump (ambulatory insulin infusion pump)
  • Modèle / numéro de série
    Animas Insulin Infusion Pump (ambulatory insulin infusion pump), models - IR 2020, 1200ARTG Number: 96120
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd