Events

Retiro De Equipo (Recall) de TCVS Heart lung machine

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
    20237
  • Fecha de inicio del evento
    2016-06-02
  • 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
    Terumo cardiovascular systems (cvs) received reports of random flow readings and/or intermittent false back flow alarms for the terumo advanced perfusion system. 1. there was no tubing in the flow sensor. when operating as intended, the module will generate '---' (three dashes) in the display, and issue a 'check sensor' alert message, when there is no tubing in the flow sensor.
  • Acción
    Product to be returned to supplier

Device

TCVS Heart lung machine

Manufacturer

Terumo Cardiovascular Systems Inc