Events

Rappel de Hospira GemStar Infusion pump

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Hospira Inc.

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
    15684
  • Date de mise en oeuvre de l'événement
    2013-11-22
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
    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
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Cause
    Hospira has become aware that some healthcare professionals may not have appropriately secured their gemstar infusion pumps via the keypad lock code. reports indicate that patients or unauthorized carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with programmed infusion parameters. one of the reports resulted in a serious injury, hospira have received no reports relating to this issue in new zealand or australia.
  • Action
    Instructions for use to be updated

Device

Hospira GemStar Infusion pump
  • Modèle / numéro de série
    Model: List numbers: 13000, 13087, 13088, 13150, 13100, Affected: All serial numbers
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    NZMMDSA