Events

Rappel de Gemstar Infusion 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 Hospira Pty Limited.

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-2013-RN-01218-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-19
  • 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-2013-RN-01218-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
  • Cause
    Through customer reports, hospira has become aware that patients or unauthorised carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with the programmed infusion parameters. hospira have received no reports relating to this issue in australia. one of the reports overseas resulted in a serious injury.
  • Action
    Hospira is recommending users change the default keypad lock code upon receipt of the device and prior to delivery to patients, and remove the clinical instructions from the manual to prevent unauthorised access. Hospira will be providing users with an updated System Operating Manual to include the requirement to change the default keypad code.

Device

Gemstar Infusion System

Manufacturer

Hospira Pty Limited
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DHTGA