Events

Alerta De Seguridad para heat exchanger

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Sorin Group Deutschland Gmbh.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1612-560
  • Número del evento
    2009EBC-0003841
  • Fecha
    2016-12-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that in studies conducted it has detected the possibility that the referenced equipment presents a risk of mycobacterium chimaera infection when they are used in open surgery procedures, because of the possibility that the water used in the equipment for temperature changes will become contaminated, because it does not follow the cleaning and disinfection instructions recommended by the manufacturer, the contaminated water could be aerosolized in the equipment and come into contact with the exposed patient, leading to the occurrence of possible adverse events on the patients.

Device

heat exchanger
  • Modelo / Serial
    HEATER COOLER 3T
  • Descripción del producto
    It is a portable refrigeration and heating device with 2 or 3 circuits (independent of the water connections) indicated for use with a heart-lung machine or for controlling the temperature of the water circuits during an extracorporeal perfusion. Includes water circuits to control the temperature of the blood (in the oxygenator), in thermal or hypothermic blankets or in the cardioplegia solutions.
  • Manufacturer
    Sorin Group Deutschland Gmbh

Manufacturer

Sorin Group Deutschland Gmbh
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    NIDFSINVIMA