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. PRIOR TO THE DEVICE INCIDENT, THE OCS APPEARED TO BE IN WORKING CONDITION WITHOUT CAUSE FOR CONCERN. THE MALFUNCTION OCCURRED AFTER LEAVING THE DONOR HOSPITAL IN ROUTE TO THE RECIPIENT CENTER. BLOOD SPLATTER ON THE BOTTOM OF OCS WAS OBSERVED. THIS WAS FOLLOWED BY REDUCED PERFUSATE FLOW AND LOSS OF PRESSURE ON THE ORGAN. TROUBLESHOOTING ATTEMPTS WERE MADE BY ADDING PRIMING SOLUTION TO MAINTAIN THE RESERVOIR VOLUMES. HOWEVER, DUE TO THE INITIALLY UNDIAGNOSED LEAK, THE TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL AND THE PERFUSATE DRAINED OUT OF THE RESERVOIR. DUE TO THE DEVICE MALFUNCTION, THE ORGAN WAS DECLINED FOR TRANSPLANT. THE MODULE WAS RETURNED TO TRANSMEDICS. TRANSMEDICS CONDUCTED AN ANALYSIS OF THE RETURNED MODULE. THE REPORTED CONDITION THAT THE MODULE LEAKED WAS CONFIRMED. THE CAUSE OF THE LEAK WAS DUE TO AN ASSEMBLY ERROR IN THE PERFUSION MODULE, I.E., THE OXYGENATOR VENT LINE NOT BEING INSERTED PROPERLY INTO THE RESERVOIR FILTER.