Description of Event or Problem · 0
THIS EVENT IS BEING REPORTED TO THE FDA AS A PART OF PROACTIVE QUALITY PLAN UNDERTAKEN BY TRANSMEDICS INC. THE REPORTABLE MALFUNCTIONS UNDER THIS QUALITY PLAN REPRESENT <0.2% OF ALL OCS TRANSPLANTS. DURING PROCUREMENT AND TRANSPORT, THE LIVER WAS STABLE AND IN GOOD CONDITION FOR ALMOST 12 HOURS BEFORE ISSUES STARTED TO OCCUR. AFTER THOSE INITIAL 12 HOURS, THE SYSTEM ALARMED AND THE TOTAL PUMP FLOWS SUDDENLY AND DRASTICALLY DECREASED AND COULD NOT BE INCREASED. THE RESERVOIR WAS OBSERVED TO BE ALMOST FULLY DEPLETED. AFTER THE ACCEPTING TEAM WAS MADE AWARE OF THE PROBLEMS, THE LIVER WAS FLUSHED AND WAS PLACED IN ICE WITH MORE PRESERVATION SOLUTION. AT THAT TIME, IT WAS TURNED DOWN FOR TRANSPLANTATION, EVEN THOUGH THE LIVER STILL FLUSHING WELL AND WAS SOFT. THE MODULE WAS RETURNED TO TRANSMEDICS. INSPECTION OF THE RETURNED PERFUSION MODULE NOTED NO VISUAL ABNORMALITIES. NO KINKED TUBES WERE PRESENT, AND NO DAMAGED PARTS WERE FOUND. THE PERFUSION MODULE'S RESERVOIR WAS CUT OPEN AND THE FILTER WAS REMOVED. A STRINGY, BIOLOGICAL TISSUE WAS VISIBLE THROUGHOUT THE INSIDE OF THE DEFOAMER AND WAS CLOGGING THE PORES OF THE DEFOAMER. A SAMPLE OF TISSUE WAS SENT OUT TO A LAB FOR ADDITIONAL TESTING, WHERE THEY WERE ABLE TO DETERMINE THE TISSUE WAS PRIMARILY THROMBUS OR CLOT. ADDITIONAL ROOT CAUSE FOR WHY THE CLOT OCCURRED COULD NOT BE DETERMINED.