Events

Rappel de GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)

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-2014-RN-00152-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-17
  • 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-2014-RN-00152-1
  • 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 complaints, hospira has become aware that in the gemstar (phase 3) infusion pumps, the connection between the beeper subassembly and the pump may fail. the gemstar infusion pump will identify this failure during the “self-test” while powering up which will result in a beeper error. this beeper error will display on the device with a service error code “code 10/001/000”. this beeper error (service code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
  • Action
    Customers are advised that there is no need to return their GemStar Phase 3 Infusion pumps at this time. If a Beeper Error occurs during power up, customers are asked to remove the device from service immediately and contact Hospira to arrange for a loan pump.

Device

GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)
  • Modèle / numéro de série
    GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)List Numbers: 13000 and 13150ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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