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
    20239
  • 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 (terumo cvs) has received reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities. some reports stated that the odor of smoke was associated with the failures. the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed.
  • Acción
    Product to be exchanged

Device

TCVS Heart lung machine
  • Modelo / Serial
    Model: Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500, Affected: Interface Module
  • Manufacturer
    Terumo Cardiovascular Systems Inc

Manufacturer

Terumo Cardiovascular Systems Inc