Events

Retiro De Equipo (Recall) de Aquarius GEF08200 Device, V4 Software

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-2013-RN-00626-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-25
  • 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-2013-RN-00626-1
  • 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
    Baxter is recalling this device due to the ability to override the total fluid balance alarm which could potentially lead to hypovolaemia or hypervolaemia. a software update was initially proposed to correct the issue for models gef08200 and gef09600, however as the software update was found to incompatible with model gef08200, baxter determined that there was no permanent solution available for this model.
  • Acción
    Hospitals are requested to provide Baxter with details of the units remaining in use. On receipt of this notification Baxter will organise for the recovery of the device. The Aquarius GEF08200 with V4 software can continue to be used until replacement devices are sourced provided the work around identified in the device Warning Label is followed. The warning label contains the following information: WARNING Repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. Beware this can cause serious patient injury. You need to identify the cause of the alarm and correct the fluid rate if necessary.

Device

Aquarius GEF08200 Device, V4 Software

Manufacturer

Baxter Healthcare Pty Ltd