Events

Alerta De Seguridad para Connector and Needle Free 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 ICU Medical 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
    R1609-403
  • Número del evento
    2011DM-0007580
  • Fecha
    2016-09-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 he has received reports of leaks in referenced devices, the risk of leakage could exist when connected to the dialysis tube during hemodialysis treatment, and can lead to blood loss, leading to potentially adverse events occurring in patients.

Device

Connector and Needle Free System
  • Modelo / Serial
    D-1000, lot 3244560
  • Descripción del producto
    Injection system used in hemodialysis and for the preparation and administration in oncology, since being a closed microbiological and mechanical system guarantees an internal flow in which the liquids that pass through the connector never come into contact with any component exposed to the environment; ideal for the use of medicines used in chemotherapy.
  • Manufacturer
    ICU Medical Inc.

Manufacturer

ICU Medical Inc.