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:
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