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. AFTER PRIMING AND INSTRUMENTATION OF THE DONOR HEART ON THE SYSTEM, DIFFICULTY WITH ECG, AND THEN AOP READINGS WAS NOTICED. ALL HEART PERFUSION MODULE (HPM) EMBEDDED SENSORS WERE LOST. THE OCS SPECIALIST CLEANED ALL THE SENSOR CONTACTS AND INSPECTED ALL THE POGO PINS. A CONSOLE RESTART WAS ALSO ATTEMPTED. DESPITE OF THESE ATTEMPTS, THEY WERE UNABLE TO OBTAIN ANY HPM READINGS. THEREFORE, THE ORGAN WAS NOT TRANSPLANTED AND THE MODULE WAS RETURNED TO TRANSMEDICS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED CONDITION THAT THE PERFUSION MODULE WAS NOT RECOGNIZED PROPERLY WAS CONFIRMED. THE MOST PROBABLE CAUSE CAN BE TRACED TO A COMMUNICATION DIODE FAILURE ON THE HPM WHICH PREVENTED COMMUNICATION BETWEEN THE HPM AND THE CONSOLE.