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. WHILE ON THE RETURN FLIGHT, AT APPROXIMATELY 3:46 MIN OF PERFUSION TIME, THE PUMP FAILED, SHOWING A RED SYSTEM FAULT ALARM INDICATING A PUMP FAILURE. IT WAS NOTICED THAT THERE WAS A LARGE AMOUNT OF AIR IN THE AO LINE. AN ATTEMPT TO RESTART THE PUMP FLOW WAS MADE BY DISENGAGING THE MODULE AND REENGAGING IT, AND GOING INTO AND OUT OF STANDBY MODE, ALL WHILE ATTEMPTING TO MANUALLY PERFUSE THE HEART BY PUMPING THE COMPLIANCE CHAMBER. WHEN COMING BACK OUT OF STANDBY AN ERROR MESSAGE WAS DISPLAYED "PUMP FAILURE, IF THIS PROBLEM PERSISTS PLEASE PERFORM MAINTENANCE". THE PUMP FAILED TO RESTART. THE CONSOLE POWER WAS CYCLED BUT UPON RESTART, THE PUMP DID START PUMPING AGAIN BUT WITH DECREASED CONTRACTILITY. APPROXIMATELY 10 MINUTES LATER THE PLANE LANDED AND PHONE SUPPORT WAS CONTACTED. AT THIS POINT THE HEART HAD LOST DETECTABLE PULSES AND WAS BARELY FIBRILLATING. THE HEART WAS TURNED DOWN THE HEART FOR TRANSPLANT. TRANSMEDICS PERFORMED A DETAILED ANALYSIS OF THE RETURNED CONSOLE BUT THE ISSUE COULD NOT BE FULLY REPLICATED. THE ROOT CAUSE OF THE PUMP FAILURE COULD NOT BE DETERMINED.