Medical device manufacturer, Terumo Cardiovascular Systems Corporation (Terumo CVS), has initiated a field safety corrective action concerning the arterial and cardioplegia monitors for Sarns Modular Perfusion System 8000.

Terumo CVS has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows:

• Monitor power malfunctions
• Inability to measure pressure
• Inaccurate pressure readings and/or false pressure alarms

Terumo CVS' initial investigation has determined that while the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, the manufacturer believes the instruction can be clarified for responding to false alarms. There are no known reports of patient injury as a result of these issues.

Furthermore, the manufacturer is notifying all affecteds users of the possibility of malfunction and reminding them to review the appropriate sections of the Operator's Manual, and providing an addendum to the Operator's Manual to clarify instruction on how to respond to a false alarm.

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 2 November 2012