Events

Retiro De Equipo (Recall) de FlexTherm Heater Cooler Device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LivaNova Australia 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-00252-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-14
  • 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-00252-1
  • 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
    After a thorough review of the flextherm heater cooler design, which has been marketed since june 2015 livanova has come to conclusion that the design concept does not fully meet user requirements. livanova has discontinued the production of the flextherm and does not intend to offer it again to the market in the future.
  • Acción
    A LivaNova representative will contact the customer to agree on the return of the affected product. LivaNova will replace the affected product with a heater cooler HC3T including new connectors and tubing at no charge. Customers may continue to safely use the heater cooler devices in accordance with the Operator’s Manual and the supplied instructions below until the necessary device removal has been completed.

Device

FlexTherm Heater Cooler Device
  • Modelo / Serial
    FlexTherm Heater Cooler DeviceProduct Code: 16-70-00Affected Serial Number in Australia: 16E01091ARTG Number: 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd