Events

Retiro De Equipo (Recall) de Spectra Optia Apheresis SystemAll Serial Numbers

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-2012-RN-00924-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-26
  • 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-00924-1
  • 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
    The manufacturer has become aware that the spectra optia system's return line air detector (rlad) can potentially fail as a result in a non-continuable alarm condition. if air has been falsely detected due to a defective rlad during a procedure, a continuous "air detected in return line" alarm will occur and will not allow the procedure to continue. if the rlad experiences a defect during prime, the system will generate a "return line air detector failed fluid check" alarm and will not allow the procedure to be performed until serviced.
  • Acción
    Terumo BCT is providing work around instructions for users to follow.

Device

Spectra Optia Apheresis SystemAll Serial Numbers

Manufacturer

Terumo BCT Australia Pty Ltd