Events

Retiro De Equipo (Recall) de MIO INFUSION SETS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INSULINPUMPS.CA 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
    86242
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-09-27
  • 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
    Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. the reported incidence rate requiring medical assistance related to thisissue is less than 1 in every 2 million infusion sets. over-delivery of insulin can cause hypoglycemia and in extreme cases death. medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid may occur if insulin alcohol or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. infusion sets currently being shipped by medtronic contain a new and enhanced membrane material that significantly reduces this risk.

Device

MIO INFUSION SETS
  • Modelo / Serial
    Model Catalog: MMT-975600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-965600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-943600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-941600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-921600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-923600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-862 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-866 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-874 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-864 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-398600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-397600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-387600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-386600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-396600 (Lot serial: >10 lot numbers cont
  • Descripción del producto
    MIO INFUSION SETS
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Dirección del fabricante
    OAKVILLE
  • Source
    HC