Events

Rappel de Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution Dual Hemo MCable Pods with Revision Index RI15 and RI16 Manufactured between August 2015 to August 2016

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger 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-2017-RN-01269-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-04
  • 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-2017-RN-01269-1
  • 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
    Dräger has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. dräger has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15 and after ri17 continue to meet the ipx4 standard.
  • Action
    Dräger are advising users to inspect systems to identify any affected products. Dräger will be providing customers with a sleeve to apply in order to prevent the issue from occurring.

Device

Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution...
  • Modèle / numéro de série
    Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring SolutionDual Hemo MCable Pods with Revision Index RI15 and RI16Manufactured between August 2015 to August 2016ARTG Number: 138056
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd