Events

Safety Alert for Platelet Separation System GPS III

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biomet Biologics || The Drucker Company || Micromedics Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1608-331
  • Event Number
    2015DM-0013853
  • Date
    2016-08-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    800-0516, 800-0505A, 800-0670A, 800-067A and 800-1003A, specific lots.
  • Product Description
    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