Events

Retiro De Equipo (Recall) de Base for Terumo Advanced Perfusion System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Terumo Cardiovascular Systems Inc.

¿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
    20534
  • Fecha de inicio del evento
    2016-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Causa
    Manufacturer has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality. symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. in one report, the ccm emitted smoke. although the occurrence for a ccm malfunction is unlikely, the possible risks of malfunction range from negligible to very severe.
  • Acción
    Instructions for use to be updated

Device

Base for Terumo Advanced Perfusion System

Manufacturer

Terumo Cardiovascular Systems Inc