Events

Retiro De Equipo (Recall) de Hospira Plum 360 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
    19230
  • Fecha de inicio del evento
    2015-10-12
  • 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 has determined if "yes" is selected at the "new patient" screen, and the program was not cleared prior to powering off the infuser, the distal occlusion pressure setting is assigned a value of 15 psi (775 mmhg) instead of the default value. in addition, the user interface will incorrectly display the default distal occlusion pressure value, which is set at 6 psi (310 mmhg) from the manufacturer.
  • Acción
    Software to be upgraded

Device

Hospira Plum 360 Infusion pump
  • Modelo / Serial
    Model: 30010-27, Affected: , Software version: 15.01.XX.009
  • Manufacturer
    Hospira Inc

Manufacturer

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