Events

Retiro De Equipo (Recall) de Hospira Sapphire 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 Q Core Medical Ltd.

¿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
    19334
  • Fecha de inicio del evento
    2015-12-04
  • 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: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Causa
    Under specfic circumstances the sapphire pump may not detect an occlusion., the resultant potential delay in therapy may happen if all of the following conditions occur:, 1. the clamp is left closed at the "start" of the treatment, and, 2. the treatment is set at epidural mode, and, 3. the programmed treatment is set to "bolus only" i.E the basal rate =0.
  • Acción
    Software to be upgraded

Device

Hospira Sapphire Infusion Pump
  • Modelo / Serial
    Model: , Affected: Software version 11.00 or lower
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd