Events

Retiro De Equipo (Recall) de Spectra Optia Apheresis System with Software Version 11

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-00963-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-05
  • 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-00963-1
  • 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
    A defect in optia version 11 sw can cause an unexpected behaviour to the rinseback option when the wbc or platelet counts are updated during the run and they are sufficiently different from the previous counts. the absence of rinseback could result in loss of rbc potentially resulting in limited illness or injury. unintended rinseback carried out on a very small patient could result in symptomatic hypervolemia. no serious injury or deaths have been associated with this behaviour.
  • Acción
    Terumo BCT is actively working on a software update to correct this behaviour. Once this software is available affected devices will be updated. End users are being provided work around instructions to ensure the continued safe use of the device. This action has been closed-out on 14/07/2016.

Device

Spectra Optia Apheresis System with Software Version 11
  • Modelo / Serial
    Spectra Optia Apheresis System with Software Version 11 Catalogue Number: 61000ARTG Numbers: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd