Events

Retiro De Equipo (Recall) de Caesarea Syringe 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 Caesarea Medical Electronics Ltd (Israel).

¿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
    23103
  • Fecha de inicio del evento
    2018-06-08
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Causa
    It has been identified that there can be a 2mm +/- overall length difference between various manufacturers pp3 batteries that could be used in niki t34 ambulatory syringe pumps., this could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
  • Acción
    Manufacturer to issue advice regarding use

Device

Caesarea Syringe Pump

Manufacturer

Caesarea Medical Electronics Ltd (Israel)