Events

Retiro De Equipo (Recall) de Sorin 1T /3T FlexTherm Systems

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
    20357
  • Fecha de inicio del evento
    2016-07-08
  • 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
    The instructions for use for the 1t and 3t/flextherm system prescribe the addition of 50ml and 150ml respectively of medical grade 3% hydrogen peroxide to the filtered tap water in the device, which results in a maximum concentration of approximately 330ppm. the purpose of adding the hydrogen peroxide is to prevent microbial growth between the regular cleaning / disinfection cycles performed every 2 weeks., the manufacturer has determined that plastic heat-exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow for diffusion of some quantity of hydrogen peroxide during a typical procedure.
  • Acción
    Manufacturer to issue advice regarding use

Device

Sorin 1T /3T FlexTherm Systems
  • Modelo / Serial
    Model: 16-02-50 16-02-80 16-02-91 16-02-82 16-02-83 16-02-85 16-02-95 and 16-70-00, Affected:
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH