Events

Rappel de Alaris GP Large Volumetric Pump (general purpose 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 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-2012-RN-01162-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-22
  • 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-2012-RN-01162-1
  • 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
    Carefusion, through its post market surveillance system, learned that the alaris gp infusion system produces very small air bubbles (less than 50ul) which are too small to trigger the lower configurable air-in-line detection thresholds (alarm) of the alaris gp infusion system - being 50-500ul, as configured by the user or 1ml over a rolling 15 min. window, which is considered state of the art and in compliance with en60601-2-24: particular requirements for the safety of infusion pumps and controllers (according to swissmedic).
  • Action
    CareFusion is providing additional information and warnings in relation to at-risk groups of patients such as those with artial septal defect, neonates and those using multiple lines.

Device

Alaris GP Large Volumetric Pump (general purpose infusion pump)
  • Modèle / numéro de série
    Alaris GP Large Volumetric Pump (general purpose infusion pump)Product Ref: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GAll serial numbersARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd