Events

Rappel de Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (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 Baxter Healthcare 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-2013-RN-00889-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-21
  • 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-00889-1
  • 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 omission has been identified in chapter 4 (operating instructions - secondary infusions) of the current revision of the operator's manual for the colleague product codes 2m91617 and 2m91637. the operator's manual should also instruct the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.
  • Action
    Baxter is providing additional information to be included in the Operator's Manual instructing users to reopen the regulating clamp after a secondary infusion has completed. Customers are requested to ensure that this information is communicated to all appropriate clinical staff and to retain the letter with the Operator's Manual. This action has been closed-out on 12/04/2016.

Device

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)
  • Modèle / numéro de série
    Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)Colleague P1.7 CXE Single Channel PumpProduct Code: 2M91617Colleague P1.7 CXE Triple Channel PumpProduct Code: 2M91637ARTG Number: 177497
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd