Events

Retiro De Equipo (Recall) de Hospira GemStar Infusion pump

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 Hospira Inc.

¿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
    14365
  • Fecha de inicio del evento
    2013-04-03
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Causa
    The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual (tsm). a pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
  • Acción
    Instructions for use to be updated

Device

Hospira GemStar Infusion pump

Manufacturer

Hospira Inc
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    NZMMDSA