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.

¿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
    I1408-333
  • Número del evento
    2009EBC-0003841
  • Fecha
    2014-08-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • 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 contamination and multiplication by mycobacterium chimera can potentially occur inside the equipment if the disinfection instructions do not match, in addition to chimaeramycobacterium contamination, these micro-bacteria may be present in tap water, this practice may lead to their occurrence potentially serious adverse events on the patient.

Device

heat exchanger
  • Modelo / Serial
    1T and 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

Manufacturer

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