Events

Retiro De Equipo (Recall) de Homechoice Pro APD System (peritoneal dialyser)

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-01117-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-01
  • 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-01117-1
  • 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
    An occluder blade clamps the solution lines if a power failure occurs or when the cycler is off preventing uncontrolled solution delivery to the patient. the occluder may contain sharp edges and/or separate from the back plate, which may cause the occluder assembly to fail resulting in an unrecoverable slowflow/no flow alarm/system error.
  • Acción
    Baxter is informing the affected hospitals of the issue. Affected devices are to be returned and replaced with unaffected devices. Baxter is advising patients if there is an unrecoverable failure to perform manual peritoneal dialysis to continue therapy.

Device

Homechoice Pro APD System (peritoneal dialyser)
  • Modelo / Serial
    Homechoice Pro APD System (peritoneal dialyser)Product Code: R5C8320Serial Number: 300905, 300882, 300928, 300889ARTG Number: 172780
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd