Events

Retiro De Equipo (Recall) de CareFusion Alaris GP Infusion 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 CareFusion Switzerland 317 Sarl.

¿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
    13823
  • Fecha de inicio del evento
    2012-11-23
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Causa
    The manufacturer has determined that the alaris gp infusion system produces very small air bubles (less than 50ul) which are too small to trigger the lowest configurable air-in-line detection alarm being 50-500ul as configured by the user, or 1ml over 15 minutes.
  • Acción
    Instructions for use to be updated

Device

CareFusion Alaris GP Infusion System
  • Modelo / Serial
    Model: Models: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G, Affected: All pumps
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl