Events

Retiro De Equipo (Recall) de CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

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-2015-RN-00099-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-05
  • 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-2015-RN-00099-1
  • 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
    Suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the cardiosave hybrid iabp console, and the inability to charge the batteries. failure to provide the correct output voltage to the console will result in the unit not functioning from ac power, even when plugged into an active electrical outlet. should a power supply malfunction occur, an on screen message will alert the healthcare provider that the cardiosave hybrid iabp unit is operating on battery power. the hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy.
  • Acción
    Users are advised that in the unlikely event that the failure mode was to occur, transfer the patient to an alternative Maquet IABP. If an alternative Maquet IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. Users are advised to refer to the IAB Instructions for Use, Manually Inflating and Deflating a Catheter. The IAB Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. Alternatively, the IAB could be removed. Maquet anticipates having a replacement power supply available by June 2015. A service representative will contact affected customers to schedule the replacement of the cart power supply. This action has been closed-out on 11/08/2016.

Device

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Modelo / Serial
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)Model Numbers: 0998-00-0800-XX and 0998-UC-0800-XX (excluding 0998-00-0800-83)ARTG Number: 118266
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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