Events

Rappel de B. Braun Infusomat Space Infusion System (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 B Braun Australia 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-00927-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-13
  • 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-00927-1
  • 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
    This is an expansion of a previous recall, initiated by b. braun in january 2012 due to the potential for breakage of the anti free flow clip located inside the infusion pump door. breakage may occur when the iv set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. misloading of the anti free flow clip catch may create the potential for free flow of medication. free flow, specially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.This recall action was not notified to the tga before it was initiated by b. braun.
  • Action
    The sponsor will be providing a software and hardware update to mitigate the issue.

Device

B. Braun Infusomat Space Infusion System (infusion pump)
  • Modèle / numéro de série
    B. Braun Infusomat Space Infusion System (infusion pump)Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or olderAffected pumps were distributed from 6 November 2008 to 29 December 2011
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd