Retiro De Equipo (Recall) de DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit)

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-2012-RN-01202-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-12-06
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Nikkiso has received complaints regarding too high a patient leakage current with the dbb-06 devices, used in combination with a central venous catheter (cvc). these complaints were related to technical measurement without any patient involvement.
  • Acción
    Baxter Healthcare is recommending work around instructions to mitigate the risk. A modification to the hardware is planned to correct the issue.

Device

  • Modelo / Serial
    DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit)Reference Numbers: GE-F110-00, GE-F111-00, GE-F112-00, GE-F114-00 & GE-F115-00All devices with serial numbers manufactured prior to 1 October 2012ARTG Number: 189947
  • Manufacturer

Manufacturer