Events

Safety Alert for CDI™ 500 Blood Parameter Monitoring System

According to Department of Health, this safety alert involved a device in Hong Kong 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
  • Date
    2012-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120310b.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 cdi™ 500 blood parameter monitoring system medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice concerning cdi™ 500 blood parameter monitoring system. in a recent review of in-house service procedures for the cdi™ 500 blood parameter monitoring system, terumo cardiovascular systems (terumo cvs) determined that replacement of the batteries should be considered “routine maintenance”. currently, system batteries that are 10 years old or older will be replaced by service technicians when a system is sent to terumo cvs for service. the current operator’s manual for the cdi 500 system does not list any routine maintenance procedures for the system. therefore, some systems may be relying on system batteries beyond their useful life. in this case, error codes may appear, and the system is at risk of losing information. there have been no reports of patient injury as a result of this issue. terumo cvs is now revising the operator’s manual for the cdi 500 system to remind operators to replace the system batteries every 10 years. according to the local supplier, affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

CDI™ 500 Blood Parameter Monitoring System

Manufacturer

Terumo Cardiovascular Systems Corporation