Events

Alerta De Seguridad para MEDRAD-BAYER Contrast Media Injector System

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 Bayer Medical Care Inc.

¿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
    R1702-37
  • Número del evento
    2016EBC-0015488
  • Fecha
    2017-02-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 referenced devices may fail in occlusion situations, when it is more than one (1) year from the date of manufacture, therefore, there may be a saline leak as a radiopharmaceutical within the ionization chamber, resulting in in the application of an incomplete dose, which could result in the need to repeat the test or could also lead to possible exposure to radiation from the operator if the chamber is open, leading to delays in the procedure or possible adverse events on the patient and user.

Device

MEDRAD-BAYER Contrast Media Injector System
  • Modelo / Serial
  • Descripción del producto
    The MEDRAD INTEGO PET INFUSION SYSTEM is an infusion system for PET INTEGO is designed to administer accurate doses of radiopharmaceutical (RP) labeled with 18f-fluorodeoxyglucose (18f-fdg) or 18f-sodium fluoride (18f-naf) and physiological solutions of Usual use during diagnostic procedures using molecular imaging (median-nuclear) techniques. The INTEGO PET infusion system is also designed to effectively protect medical personnel from radiation exposure to fluoride-18 (18f) during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Medical Care Inc

Manufacturer

Bayer Medical Care Inc
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    NIDFSINVIMA