Events

Safety Alert for CDI Blood Parameter Monitoring System 500

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Terumo Cardiovascular System.

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
  • Date
    2011-09-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110930.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: terumo cvs cdi blood parameter monitoring system 500 medical device manufacturer, terumo cardiovascular system (terumo cvs), has issued an urgent field safety notice concerning cdi blood parameter monitoring system 500 distributed during the period october 2009-may 2011. during functional testing, terumo cvs identified a defective integrated circuit on the main circuit board in the cdi blood parameter monitoring system 500. this integrated circuit could potentially cause cdi system 500 not to function after a loss of power, either upon intentional power down or due to an unexpected power outage. in this case, the monitor would display error codes upon restart, and would not be useable. there have been no confirmed complaints from cdi system 500 users on this issue. according to the local supplier, hk is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

CDI Blood Parameter Monitoring System 500
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo CVS CDI Blood Parameter Monitoring System 500
  • Manufacturer
    Terumo Cardiovascular System

Manufacturer

Terumo Cardiovascular System