Important Safety Alerts

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 multiple reports since September 2008 of various malfunctions of the Sarns™ Centrifugal System for the Terumo® Advanced Perfusion System 1 in which the user was unable to achieve or maintain the desired flow rate.

Their investigation revealed that a number of root causes contributed to the failures. The probability of the malfunction occurring in the affected population is rare – less than 0.00318% of uses. The manufacturer is creating an addendum to the Operator's Manual for the Terumo System 1 centrifugal system which includes the following:

• Updates the instructions for responding to drive motor failure.
• Reinforces the recommendation to have back-up equipment for the centrifugal system available during cardiopulmonary bypass.
• Recommends that users consider the use of a one-way valve to prevent retrograde flow in the arterial line of the cardiopulmonary bypass circuit.

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