Events

Rappel de Organ Care System (OCS) Heart system - OCS Heart Console

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Transmedics 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-00724-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-05
  • 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-00724-1
  • 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
    The manufacturer has identified a potential issue with the ocs heart device that could affect proper operation. in particular, the blood warmer may heat beyond the set limit if the heart perfusion module (hpm) is not installed in the ocs console prior to taking the system out of standby mode. use of the ocs heart device to support an organ at an elevated temperature may result in organ damage and/or turndown of organ for transplantation.
  • Action
    TransMedics will be correcting this issue through an update to the software and Instructions For Use (IFU). In the interim, users are to follow the directions in the Product Information Bulletin provided with the customer letter. The Bulletin describes the recommended sequence for installing the HPM into the OSC Console. In order to ensure proper performance, such as maintaining the configured blood temperature, users are to include the HPM in the system’s Self-Test by installing the HPM in the OCS Heart Console while the system is in Standby Mode.

Device

Organ Care System (OCS) Heart system - OCS Heart Console
  • Modèle / numéro de série
    Organ Care System (OCS) Heart system - OCS Heart ConsoleOSC Heart Console Reference Number: 1200Serial Numbers: 2486-1-15132, 2486-1-15129, 4929-4-15182ARTG Number: 146269
  • Manufacturer
    Transmedics Pty Ltd

Manufacturer

Transmedics Pty Ltd
  • Source
    DHTGA