Events

Retiro De Equipo (Recall) de Spectra Optia Apheresis System - Return Line Air Detector (RLAD)

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-2014-RN-00886-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-27
  • 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-00886-1
  • 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
    Terumo bct has redesigned the return line air detector (rlad) component of the spectra optia apheresis system. this redesign will further reduce the low occurrence of false air detections during a procedure; the plan has been to install the replacement component on devices in which a rlad false air detect has occurred.
  • Acción
    Terumo BCT is replacing the existing RLAD sensor with the redesigned component on all Spectra Optia systems in Australia. If false air detections have occurred on a system in the last 12 months the upgrade will be scheduled as soon as possible. Where no issues have been reported the RLAD sensor will be replaced during the next scheduled preventative maintenance visit. This action has been closed-out on 03/05/2016.

Device

Spectra Optia Apheresis System - Return Line Air Detector (RLAD)
  • Modelo / Serial
    Spectra Optia Apheresis System - Return Line Air Detector (RLAD)ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd