Events

Retiro De Equipo (Recall) de 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
    19740
  • Fecha de inicio del evento
    2016-02-10
  • 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 three reports of a terumo® advanced perfusion system 1 displaying a pressure reading of '999'. terumo cvs has confirmed that in one of these cases, the user was unable to clear the pressure alarm and restart the pump., note: the system displays '999' at pressures greater than +900mmhg. the reading can indicate a true high pressure or a malfunction of the pressure transducer or cable.
  • Acción
    Manufacturer to issue advice regarding use

Device

Terumo Advanced Perfusion System

Manufacturer

Terumo Cardiovascular Systems Inc