Events

Safety Alert for equipment for collection, processing and infusion of blood by apheresis

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fenwal, International 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
    I1512-589
  • Event Number
    2006DM-0000382
  • Date
    2015-12-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
  • 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 has detected software anomalies when automated preparation of platelets stored with active solution and under specific conditions causing incorrect calculation of plasma volume, leading to potential failure in the cell count.

Device

equipment for collection, processing and infusion of blood by apheresis
  • Model / Serial
    Cell Separators (PAS), reference 4R4580, 4R4580R and 4R4580TH.
  • Product Description
    For collection of blood components with the CS blood cell separator, prolonged storage of platelets and collection of plasma and red blood cells with the blood cell separator AMICUS. Collection of mononuclear cells and plasma.
  • Manufacturer
    Fenwal, International Inc

Manufacturer

Fenwal, International Inc