Events

Retiro De Equipo (Recall) de Trima Accel Automated System (Apheresis unit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Terumo BCT 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-2013-RN-00377-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-29
  • 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-00377-1
  • 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
    There is the potential risk for an air embolism if air is delivered to a donor if the donor is connected prior to completion of loading the tubing set when using the trima accel system.
  • Acción
    Terumo BCT is implementing a safety enhancement in the Trima Accel system software version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. This new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line.

Device

Trima Accel Automated System (Apheresis unit)
  • Modelo / Serial
    Trima Accel Automated System (Apheresis unit)Catalogue Number: 81000All serial numbers affectedARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd