Events

Retiro De Equipo (Recall) de MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Imaxeon 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-2014-RN-00426-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-11
  • 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-2014-RN-00426-1
  • 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
    Bayer healthcare is recalling brackets used to mount the continuum pump on the iv pole distributed with non-wireless versions of medrad continuum mr infusion systems prior to march 2008. these brackets are being recalled because of a potential safety risk in the mri environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the mri magnet.
  • Acción
    Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.

Device

MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008

Manufacturer

Imaxeon Pty Ltd
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DHTGA