Events

Rappel de Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion 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 CareFusion Australia 316 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-00584-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-14
  • 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-00584-1
  • 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
    Post market surveillance has identified an increased occurrence of stepper motor stalls due to the rear bearings not performing as designed.A motor stall condition may occur during:- start up (immediately after the start key is pressed) or;- during an infusion which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.In either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - "drv1" or "drv2" and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene.
  • Action
    End users are requested to identify all affected infusion pumps and report back to their Carefusion representative. On receipt of this information Carefusion will organise for the replacement of the motor. The infusion pumps can be continued to be used in accordance with the instructions for use. In the unlikely event that end users experience a 'DRV1' or 'DRV2' error quarantine the pump and contact your Carefusion representative immediately.

Device

Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps
  • Modèle / numéro de série
    Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion PumpsProduct reference numbers: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GPumps manufactured between Dec 2009 and Jan 2012ARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd