Events

Retiro De Equipo (Recall) de B. Braun Infusomat Space Infusion System (infusion pump)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun Australia 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-00927-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-13
  • 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-2012-RN-00927-1
  • 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
    This is an expansion of a previous recall, initiated by b. braun in january 2012 due to the potential for breakage of the anti free flow clip located inside the infusion pump door. breakage may occur when the iv set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. misloading of the anti free flow clip catch may create the potential for free flow of medication. free flow, specially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.This recall action was not notified to the tga before it was initiated by b. braun.
  • Acción
    The sponsor will be providing a software and hardware update to mitigate the issue.

Device

B. Braun Infusomat Space Infusion System (infusion pump)
  • Modelo / Serial
    B. Braun Infusomat Space Infusion System (infusion pump)Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or olderAffected pumps were distributed from 6 November 2008 to 29 December 2011
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd