Events

Safety Alert for Apheresis Equipment TRIMA ACCEL TERUMO

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Terumo Bct Inc || Terumo Bct Vietnam Co., Ltd..

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
    I1702-58
  • Event Number
    2009EBC-0004625
  • Date
    2017-02-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 informs that the reel iv pole of the referenced system can fall quickly and forcefully once the deliberation button of the hanger is pushed if the operator does not hold it as it loosens, it can fall with enough force to cause an injury to the operator. , if your hands are in the path of the descending guide, leading to the occurrence of potentially adverse events on the users.

Device

Apheresis Equipment TRIMA ACCEL TERUMO
  • Model / Serial
  • Product Description
    This equipment is for exclusive use with the medical device indicated for obtaining red blood cells, plasma and platelets by apheresis of healthy donors.
  • Manufacturer
    Terumo Bct Inc || Terumo Bct Vietnam Co., Ltd.

Manufacturer

Terumo Bct Inc || Terumo Bct Vietnam Co., Ltd.