Events

Retiro De Equipo (Recall) de Organ Care System (OCS) Heart system - OCS Heart Console

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Transmedics Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00724-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00724-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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