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
    20973
  • Fecha de inicio del evento
    2016-12-21
  • 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
    The manufacturer has received reports of instances in which the 6 roller pump for the terumo advanced perfusion system 1 displayed a pump jam message and stopped while in use. investigation concluded that, while there is no specific evidence that the 6 roller pumps were operating outside manufacturing specifications:, 1. pump jam is more likely to occur when using the 6 roller pump for low-rpm cardioplegia delivery than when using the 4 roller pump for dual-sized tube set cardioplegia delivery., 2. the occlusion settings suggested in the operator's manual for some dual-sized tubing sets may increase the likelihood of pump jam on the 6 roller pump.
  • Acción
    Manufacturer to issue advice regarding use

Device

TCVS Heart lung machine

Manufacturer

Terumo Cardiovascular Systems Inc