Events

Retiro De Equipo (Recall) de Artis Dialysis System equipped with SW 8.15.06 and 8.33.02

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gambro 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-00057-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-22
  • 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-00057-1
  • 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
    Depending on the type of dialyzer membrane being used, excess foam may be generated in the venous circuit during patient connection and during the first few minutes of treatment. this specific condition is clearly visible to the operator.This issue was found to be primarily due to residual humidity in the fibers of the dialyzers with air permeable membranes. this problem has not been reported in dialyzers with non-air permeable membranes.None of the incidents reported resulted in a serious patient injury or medical intervention to preclude serious injury.
  • Acción
    An Operator Manual Addendum is being prepared and expected to be released Q3 2015. In the interim the Customer Letter details the new instructions. This action has been closed-out on 18/07/2016.

Device

Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Modelo / Serial
    Artis Dialysis System equipped with SW 8.15.06 and 8.33.02ARTG Number: 141189
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd