Events

Retiro De Equipo (Recall) de HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2012-RN-01015-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-02
  • 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-2012-RN-01015-1
  • 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
    In some very rare cases, it was not possible to insert the guide wire through the introducer of the hls-cannulae. the investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. the problem occurs prior to vascular access and the cannulae itself functions properly during perfusion.
  • Acción
    Quarantine and return affected devices to MAQUET

Device

HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as ...
  • Modelo / Serial
    HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)Multiple catalogue and lot numbersARTG Numbers: 188929 and 189286
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA