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 <(B)(4) % OF ALL OCS TRANSPLANTS. DURING THE RETURN FROM PROCURING A DCD HEART, THE SYSTEM WAS UNABLE TO ACHIEVE PERFUSATE TEMPERATURES GREATER THAN THE HIGH 20S C. HEART FIBRILLATION WAS OBSERVED AND THE DONOR ORGAN WAS DECLINED DUE TO THE MALFUNCTION. THE HEART PERFUSION MODULE (HPM) WAS DISPOSED AT THE DONOR HOSPITAL AND WAS NOT RETURNED TO TRANSMEDICS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED CONDITION THAT THE SYSTEM WOULDN'T HEAT THE PERFUSATE WAS CONFIRMED. TRANSMEDICS ANALYZED THE SESSION FILES AND IDENTIFIED THAT CONSOLE WAS UNABLE TO READ THE EEPROM FROM THE PERFUSION MODULE. IF THE EEPROM CANNOT BE READ, THE CONSOLE WILL NOT SEND POWER TO THE HEATERS TO WARM THEPERFUSATE. HOWEVER, THE CAUSE OF THE ERROR COULD NOT BE DETERMINED.