Events

Safety Alert for Advanced Perfusion System 1

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
    2012-08-17
  • Event Date Posted
    2012-08-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817b.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
    Medical device safety alert: terumo advanced perfusion system 1 medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning terumo advanced perfusion system 1. terumo cardiovascular systems (terumo cvs) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500 some reports stated that the odor of smoke was associated with the failures. according to the manufacturer, the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed. based on the information provided by the local supplier, the affected products have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation