Events

Retiro De Equipo (Recall) de ENTERALITE INFINITY ENTERAL FEEDING PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED 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
    27891
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-29
  • 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
    The pump uses an optical sensor to detect the presence of fluid or air in the administration set which is why at the completion of a feeding it is expected that the pump will alarm as outlined above. however residual clumps from certain types of feeding preparations may be interpreted by the sensor as food remaining in the administration set causing the pump to continue to run despite the bag being empty. this situation likely occurs with home blended or prepared food as well as non-traditional additives such as fortifiers lipids proteins etc. if the sensor is obstructed by sticky solids it may cause the pump to continue running and cause an overrun failure and may potentially deliver air to the users.

Device

ENTERALITE INFINITY ENTERAL FEEDING PUMP
  • Modelo / Serial
    Model Catalog: INFKIT2 (Lot serial: >1000 numbers contact mfg")
  • Descripción del producto
    ENTERALITE INFINITY FEEDING PUMPS
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC