Events

Alerta De Seguridad para thoracic drains Atrium

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 Atrium Medical Corporation.

¿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
    I1612-584
  • Número del evento
    2008DM-0001833
  • Fecha
    2016-12-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 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 deadvertence labels are being revised for the labeling of the chest drains, in order to inspect the current configuration of the container, clarifying that part of it is sterile, the affected product is packaged with a sterile double sequential wrap, a cover is placed external protective dust, and then bends and secures with the packaging label, the drain is sterile inside the container but the external dust cover is not, leading to possible serious adverse events on the patient.

Device

thoracic drains Atrium
  • Modelo / Serial
  • Descripción del producto
    ATRIUM thoracic drains are non-invasive disposable systems of multi-chamber vessels with valves, port and suction regulators, fluid or air collection chamber, vacuum and leakage indicators and suction connectors designed to: evacuate fluids or air from the chest cavity or mediastinomediante succión and collect them in the container or chamber ofdesecho. Help restore the lungs expansion and restore respiratory dynamics, by means of the achieved drainage. Facilitate the early evaluation of postoperative patients who require chest drainage, through the achieved drainage.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NIDFSINVIMA