Retiro De Equipo (Recall) de Medfusion 4000 Syringe Infusion Pump

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Smiths medical has identified an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may appear at the ac power receptacle. the pump and the ac power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. there is a potential for delay in treatment while a replacement or alternative method of delivery is obtained.
  • Acción
    Smiths Medical is advising users to immediately unplug the AC power cord from the power source if there are signs of sparking, flames or smoke emitting from the unit. Smiths Medical is providing work around instructions for users to follow until Smiths Medical develops a permanent fix.