Events

Retiro De Equipo (Recall) de Advanced Perfusion System 1 (heart-lung bypass machine)

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 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-01216-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-11-29
  • 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-2012-RN-01216-1
  • 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 received five reports between 2003 and 2012 of spontaneous power loss to the terumo system 1. in all reports the systems lost full power and did not switch to battery backup without warning. in one report the system re-booted automatically after about 30 seconds and in the remaining reports the system regained power after toggling the main power switch. in all of the reports the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.
  • Acción
    An update to the instructions for use (IFU) is being issued to customers as an interim measure and the manufacturer's investigation into the root cause investigation is ongoing. Terumo is advising that should the investigation conclude that a corrective action is necessary, users will be notified.

Device

Advanced Perfusion System 1 (heart-lung bypass machine)
  • Modelo / Serial
    Advanced Perfusion System 1 (heart-lung bypass machine)Product Code: 801764Batch Numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027 & 1100-1429ARTG Number: 93976
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd