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. THE USER REPORTED THAT AFTER AROUND 2 HOURS AND 20 MINUTES OF PERFUSION TIME, THE RESERVOIR CHAMBER STARTED TO LEAK. THIS RESULTED IN A TURN DOWN OF THE DONOR ORGAN. THE MODULE AND A VIDEO OF THE EVENT WERE RETURNED TO TRANSMEDICS. ANALYSIS OF THE VIDEO NOTED THAT THE RESERVOIR BLOOD LEVEL WAS VERY LOW, AND IT APPEARED AS THOUGH BLOOD WAS BACKED UP IN THE RESERVOIR FILTER. THIS INDICATES THAT A CLOG WAS PRESENT IN THE FILTER, AND IT WAS BACKING UP SO MUCH THAT IT STARTED TO OVERFLOW AND LEAK OUT OF THE RESERVOIR. IT WAS NOTED THAT THE USER OBTAINED DONOR BLOOD USING A CELL SAVER, WHICH IS NOT A RECOMMENDED METHOD ACCORDING TO THE USER GUIDE. THIS MAY HAVE RESULTED IN THE FORMATION OF BLOOD CLOTS WHICH THEN LED TO THE FILTER CLOGGING. BASED ON THE AVAILABLE INFORMATION, THE REPORTED CONDITION THAT THE RESERVOIR LEAKED WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE FOUND NO DEFECT OR NONCONFORMANCE. THE CAUSE OF THE LEAK WAS LIKELY DUE TO THE RESERVOIR FILTER CLOGGING. IT IS LIKELY THAT THE FILTER CLOGGED FROM BLOOD CLOTS, WHICH MAY HAVE FORMED BECAUSE THE USER DID NOT COLLECT BLOOD USING THE RECOMMENDED METHODS FROM THE USER GUIDE.