Events

Retiro De Equipo (Recall) de Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post

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-2013-RN-00086-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-01
  • 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-00086-2
  • 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
    Gambro has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the integra and ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet.
  • Acción
    Gambro is providing additional instructions for use for the correct blood level setting in the venous chamber. In addition, Gambro will discontinue the new design and re-introduce the original design.

Device

Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tub...
  • Modelo / Serial
    Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post;Product Code 114635, Batch Numbers from 1240 to 1303BL208BD;Product Code:114557Batch numbers from 1242 to 1304BL223 PB;Product Code: 114636Batch Numbers from 1252ARTG Number: 141589
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd