Events

Retiro De Equipo (Recall) de Curlin Medical 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 Moog Medical Devices Group 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
    19678
  • Fecha de inicio del evento
    2016-01-19
  • 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: Biomed Limited, 52 Carrington Road, Point Chevalier, AUCKLAND
  • Causa
    Master pumps used to calibrate curlin infusion pumps manufactured or serviced from march 18, 2015 to november 6, 2015 were out of tolerance.Use of affected pumps may cause an over-delivery of medications and solutions at a rate of 1.2 – 6.8% faster than programmed. likewise, the volume to be infused may be depleted earlier than expected, resulting in over delivery of overfill contained in the iv bag, if overfill is present. if overfill is not present, the pump may present an air in line or upstream occlusion alarm once the iv bag has emptied. the pump will stop infusing when either of these alarms occurs.
  • Acción
    Product to be returned to supplier

Device

Curlin Medical infusion pump

Manufacturer

Moog Medical Devices Group Inc
  • Empresa matriz del fabricante (2017)
    Moog Inc.
  • Source
    NZMMDSA