Events

Retiro De Equipo (Recall) de MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    63847
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-02-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Since october 2010 smiths medical has received a total of 4 complaints regarding system errors that cause the medfusion 4000 pump to stop running. there have been no reports of patient injury or death. investigation has identified the root cause to be related to a software anomaly that originated during development that causes a particular history log corruption to occur. further under infrequent circumstances the normal error recovery mechanism for the history corruption (i.E. clear history) is not successful. when the recovery mechanism is not successful the "watchdog fail-safe" alarm is triggered. the combination of the corruption and unsuccessful recovery results in a persistent re-occurrence of the "watchdog fail-safe" on every power-up preventing further use of the pump.

Device

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
  • Modelo / Serial
    Model Catalog: 4000-0100-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0101-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0100-249 (Lot serial: > 10 CONTACT MANUFACTURER)
  • Descripción del producto
    Medfusion 4000 Syringe Pump
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC