Events

Retiro De Equipo (Recall) de Sorin 3T Heater Cooler with Remote

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 Sorin Group Deutschland GmbH.

¿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
    17069
  • Fecha de inicio del evento
    2014-07-30
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    Newly identified risk for cardiac surgery patients whereby some patients have been infected with a slow growing mycobacterium chimaera. this organism is found in water including tap water sources., important to review hygiene and surgical practices in the cardiac surgery theatre. this review should include sampling and monitoring programs for water sources solution preparations and systems that use water in the cardiac surgery theatre. among these water systems, heater cooler device(s) need strict adherence to the cleaning disinfection and maintenance according to the operator manual for sorin devices.
  • Acción
    Manufacturer to issue advice regarding use

Device

Sorin 3T Heater Cooler with Remote

Manufacturer

Sorin Group Deutschland GmbH