Medical device manufacturer, Terumo® Cardiovascular Systems (CVS) Corporation, has issued an urgent field safety notice concerning Terumo® Advanced Perfusion System 1.
The manufacturer has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality.
Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. In one report, the CCM emitted smoke. Their preliminary investigation found the failures were due to design or supplier workmanship issues.
The probability of patient injury caused by this malfunction is low because all the primary functions and controls on the CCM can be maintained through the Terumo System 1's local controls. There have been no reports of patient injury as a result of this issue. The manufacturer is providing an Addendum to the Operator's Manual for Terumo System 1 with instruction on what to do in the event of a CCM malfunction.
According to the local supplier, the affected devices were not distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 July 2012