Events

Retiro De Equipo (Recall) de Spectra Optia Apheresis Systems

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-2017-RN-00626-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-16
  • 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-2017-RN-00626-1
  • 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
    During routine testing by the manufacturer, a device that is similar to the spectra optia system demonstrated a non-recoverable power failure. a subsequent investigation determined that a power filter cable, a component used in the internal electrical system, had a visible defect that caused the unit to lose power. specific serial numbers of the spectra optia systems contain these cables and therefore there is a possibility these systems could encounter a non-recoverable power failure. if a power failure occurs prior to starting the procedure, the failure could result in the delay of the procedure until the device is repaired or another device is available. if a power failure occurs after the procedure has begun, the procedure cannot be completed, and automated rinseback cannot be performed.To date, the manufacturer has not received any customer reports of a non-recoverable power failure experienced in any spectra optia system with the possibly affected cables.
  • Acción
    Terumo is advising users that they will be replacing the affected cables. A Terumo sales representative will contact users to schedule a visit for the cable replacement. In the interim, the Spectra Optia system can continue to be used in accordance with the operator’s manual and the operator training materials, which include instructions for manual rinseback.

Device

Spectra Optia Apheresis Systems
  • Modelo / Serial
    Spectra Optia Apheresis SystemsSerial Number Range: 1P04028 to 1P04392ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd