Events

Retiro De Equipo (Recall) de CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2018-RN-00603-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-06-29
  • 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-2018-RN-00603-1
  • 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
    Getinge has received complaints involving the cardiosave iabps regarding ingress of fluids into the iabp affecting various electronic circuit boards. this situation would prevent initiation or continuation of therapy. to date, getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress.
  • Acción
    Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test. Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP

Device

CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIO...
  • Modelo / Serial
    CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS Part Numbers: 0997-00-0562 and 0997-001-1179ARTG Number: 118266(Getinge Australia Pty Ltd - Circulatory assist unit, pump, balloon)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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