Description of Event or Problem · 0
A HEART FROM ORGAN DONOR (B)(6) WAS ACCEPTED BY (B)(6) HOSPITAL LOCATED IN (B)(6), FOR THEIR PATIENT. (B)(6) CONTRACTED TRANSMEDICS TO RECOVER THE HEART AND PLACE ON THE HEART PRESERVATION PUMP. TRANSMEDICS SUCCESSFULLY RECOVERED THE HEART AND PLACED IT ON THE PUMP. INITIALLY, THE PUMP WAS OPERATING AS INTENDED. APPROXIMATELY 20 MINUTES LATER, A COMMUNICATION FAILURE WAS IDENTIFIED BETWEEN THE MODULE AND CONSOLE OF THE DEVICE. THIS RESULTED IN THE PUMP FLOW NOT BEING REGULATED. THE HEART THEN FIBRILLATED AFTER APPROXIMATELY 1.5 HOURS LATER AND RESULTED IN THE LOSS OF THE HEART FOR TRANSPLANTATION. THE TRANSMEDICS ORGAN CARE SYSTEM OPERATOR COMMUNICATED TO GIFT OF LIFE DONOR PROGRAM THAT THE CONSOLE WAS BEING SENT BACK TO ANDOVER, MA FOR EVALUATION AND REPAIR. ON (B)(6) 2024, TRANSMEDICS PROVIDED RESULTS OF THEIR INVESTIGATION BASED UPON AVAILABLE EVIDENCE. THEY COMMUNICATED THAT THE MOST PROBABLE ROOT CAUSE OF THE COMMUNICATION FAILURES CAN BE TRACED TO A NON-FUNCTIONAL COMMUNICATION DIODE ON THE PRINTED CIRCUIT BOARD. FURTHERMORE, A DETAILED INVESTIGATION IDENTIFIED A SUBOPTIMAL PROCESS DURING THEIR BOARD SUPPLIER'S MANUFACTURING AS ROOT CAUSE - THE PROCESS CAUSED UNDUE STRESS ON THE DIODE ON THE MODULE'S PRINTED CIRCUIT BOARD WHICH ALLOWED IT TO FUNCTION PROPERLY DURING THE FINAL TEST BUT EXHIBIT DELAYED FAILURE DURING USE.