Events

Alerta De Seguridad para Brachytherapy Systems

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 Nucletron Operation B.V..

¿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
    A1708-389
  • Número del evento
    2013EBC-0010303
  • Fecha
    2017-08-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • 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 states that the routes of the measured sources of the referenced applicators, with a step size of the source of 2.5mm for the microselectron deferred charging device, constitutes the source of the alert, if this model of applicator is used to create an unplan, although the size of the step of the default source of the deferred loading device is 5.0mm, the size of the ovoid passage in the form of a ring or semicircular will be incorrect, 2.5 m will be indicated, although the deferred loading device will administer a dose at 5.0 mm. the error is detected during the approval of the plan, which may lead to the occurrence of potentially serious adverse events on the patient.

Device

Brachytherapy Systems
  • Modelo / Serial
    Oncentra Brachy Planning System Version 4.5
  • Descripción del producto
    Indicated for an operator to apply, by remote control, a radioactive source in the body through an interstitial, intracavitary, intraluminal, bronchial, endovascular, intraoperative applicator, radiation therapy for the treatment of cancer. Transplant applicators and tubes, an integral part of the brachytherapy system, are used to apply the radiation directly to the patient at the specific sites selected by the physician and are the only part of the system that has contact with the patient.
  • Manufacturer
    Nucletron Operation B.V.

Manufacturer

Nucletron Operation B.V.
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NIDFSINVIMA