Events

Alerta De Seguridad para Platelet Separation System GPS III

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 Biomet Biologics || The Drucker Company || Micromedics 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
    R1608-331
  • Número del evento
    2015DM-0013853
  • Fecha
    2016-08-05
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • 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 it has detected that the referenced devices may have the sterile barrier compromised by defects in the vial of 30ml, leading to its use causing possible adverse events on the patients.

Device

Platelet Separation System GPS III
  • Modelo / Serial
    800-0516, 800-0505A, 800-0670A, 800-067A and 800-1003A, specific lots.
  • Descripción del producto
    The platelet separation system GPS® III with ACD-A, allows the separation of the components of the patient's own blood by density through the use of a laboratory centrifuge machine, quickly preparing platelet concentrates from a reduced volume of the patient's blood extracted during the surgical procedure. The system is designed for the safe and rapid collection of autologous platelet-rich plasma (PRP). The PRP can be prepared and applied during the surgical procedure as deemed necessary by the clinical use requirements. In addition, it can be used to improve the use of bone grafts.
  • Manufacturer
    Biomet Biologics || The Drucker Company || Micromedics Inc

Manufacturer

Biomet Biologics || The Drucker Company || Micromedics Inc
  • Source
    NIDFSINVIMA