Events

Retiro De Equipo (Recall) de Baxter FOLFusor SV 0.5ml/hr

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 SA (Switzerland).

¿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
    16552
  • Fecha de inicio del evento
    2014-04-17
  • 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 has continued to investigate complaints for over-infusion and wants to make customers aware that the direction insert states that infusion rates may be up to 10% greater than the nominal (labeled) infusion rate of 0.5ml/hr. recent review of flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal (labeled) infusion rate., baxter is considering options to bring the flow rate into alignment with curent labeling.
  • Acción
    Instructions for use to be updated

Device

Baxter FOLFusor SV 0.5ml/hr

Manufacturer

Baxter Healthcare SA (Switzerland)