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 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
    2012-01-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126a.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™ blood parameter monitoring system 500 medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice on the use of cdi™ blood parameter monitoring system 500. the manufacturer identified that contact between the power cables and the sharp edge of the chassis can potentially damage the cables’ insulation. this could result in an electrical short, which could further create sparking, fire, smoke, shock or monitor failure. there have been no reports of occurrence of this issue or patient injury as a result of this issue. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

CDI™ Blood Parameter Monitoring System 500

Manufacturer

Terumo Cardiovascular Systems Corporation