Events

Retiro De Equipo (Recall) de Hospira GemStar Docking station

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
    15721
  • Fecha de inicio del evento
    2013-11-29
  • 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.
    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
    Hospira inc. has become aware of two situations that may occur when using the gemstar docking station list numbers 13075-xx-07 and 13075-xx-09 in conjunction with the gemstar infusion pump., when the docking station is used in conjunction with a gemstar phase 3 infusion pump (list numbers 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station., when a gemstar phase 4 infusion pump (list numbers 13086-xx, 13087-xx or 13088-xx) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx), there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • Acción
    Instructions for use to be updated

Device

Hospira GemStar Docking station

Manufacturer

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