Events

Safety Alert for Monitoring System Blood Parameters CDI 500

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Terumo Cardiovascular Systems Corporation.

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
    A1601-25
  • Event Number
    2010EBC-0005323
  • Date
    2016-01-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • 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 refers to a situation that could arise with the cuvette cdi h / s and recommends what should be done if the cdi 500 blood parameters monitoring system displays the "h / sdisconnect at cuvette" error message on the screen in this condition the values of the blood parameters for hematocrit, hemoglobin and o2 saturation are not visualized, this is the result of the use of a product from a supplier, leading to the potential occurrence of adverse events on the patients or delays in the time of the procedure.

Device

Monitoring System Blood Parameters CDI 500
  • Model / Serial
    6912, 6913 and 6914, lots TC16, TF11, TE13 and TG08
  • Product Description
    This equipment allows the monitoring of blood parameters numerically and graphically on the screen, indicating arterial gases, potassium, venous saturation, hematocrit, hemoglobin and temperature. This is done during the procedures of heart surgery, lung, among others
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation