Events

Rappel de PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gambro 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-2014-RN-00785-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-30
  • 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-00785-1
  • 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
    Gambro has learned of difficulties of disconnection and/or leaks at the level of luer connections on disposable prisma, prismaflex, x-mars and adsorba sets. these conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting, for example, from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances, the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.
  • Action
    This action has been closed-out on 01/11/2017.

Device

PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Modèle / numéro de série
    PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd