Events

Retiro De Equipo (Recall) de Baxter Clearlink Solution Sets

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 Baxter Healthcare Corporation.

¿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
    15021
  • Fecha de inicio del evento
    2013-07-29
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    Manufacturer received feedback from a customer that an iv tube could not be loaded into a infusion pump because the side clamp was not correctly assembled. manufacturer confirmed that the complaint sample and confirmed side clamp assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may withdrawn froma patient and result in acute blood loss and/ or delay in treatment of life sustaining medication as worst case scenario.
  • Acción
    Product to be returned to supplier

Device

Baxter Clearlink Solution Sets

Manufacturer

Baxter Healthcare Corporation