Description of Event or Problem · 0
DURING TRANSPORT FROM THE AIRPORT TO THE RECIPIENT HOSPITAL, THE VEHICLE HIT A LARGE POTHOLE AND THE AORTIC CANNULA DISENGAGED FROM THE ORGAN CHAMBER. THE CANNULA WAS STILL CONNECTED TO THE ORGAN ITSELF. THE SPECIALIST REATTACHED THE CANNULA TO THE ORGAN CHAMBER WITHOUT DISTURBING THE STERILE BARRIER, BUT THE ORGAN WAS DISCONNECTED FOR APPROXIMATELY 8 MINUTES WITHOUT BLOOD FLOW DURING TRANSIT TO THE HOSPITAL. AFTER THE CANNULA WAS REATTACHED, THE ORGAN WAS ON THE SYSTEM FOR AN ADDITIONAL 1.5 HOURS UNTIL THE ORGAN WAS TRANSPLANTED. IT WAS NOTED THAT THE ORGAN WAS FIBRILLATING AFTER THE CANNULA DISCONNECTED, AND IT WAS MASSAGED UNTIL THE OR WAS REACHED, WHERE THE SPECIALIST SHOCKED THE HEART AND SINUS RHYTHM WAS RESTORED. BOTH THE ARTERIAL AND VENOUS LACTATES WERE TRENDING DOWNWARD AND THE RECIPIENT TRANSPLANT SURGEON ACCEPTED THE DONOR HEART FOR TRANSPLANT ON (B)(6) /2024 BASED ON CLINICAL ASSESSMENT ON OCS. TRANSMEDICS CONDUCTED COMPREHENSIVE INVESTIGATION OF THE REPORTED ISSUE AND DID NOT IDENTIFY ANY NONCONFORMANCE. SINCE THE PHYSICAL DEVICE WAS NOT RETURNED, THE DEFINITIVE ROOT CAUSE OF THE CANNULA DETACHMENT COULD NOT BE DETERMINED. HOWEVER, IT IS MOST LIKELY THAT ROUGH TRANSPORT PLAYED A SIGNIFICANT ROLE IN THE DETACHMENT OF THIS CANNULA SINCE VISUAL ANALYSIS OF A VIDEO TAKEN BY THE SPECIALIST NOTED THAT PRIOR TO DEPARTURE FROM THE DONOR HOSPITAL, THE AORTIC CONNECTOR APPEARED TO BE ATTACHED TO THE ORGAN CHAMBER PROPERLY. AS PART OF VALIDATION AND VERIFICATION TESTING, THE HEART AORTIC CANNULA WAS PUT THROUGH SHOCK AND VIBRATION TESTING ACCORDING TO IEC 60068-2-64 AND IEC 60068-2-27. DURING THESE TESTS, THE AORTIC CANNULA WAS ATTACHED TO A PORCINE HEART, AND AT NO POINT DID THE AORTIC CANNULA EVER LOOSEN OR DETACH FROM THE ORGAN CHAMBER. TRANSMEDICS WAS MADE AWARE ON 7/21/2024 THAT THE RECIPIENT OF THIS ORGAN EXPERIENCED POST-OP COMPLICATIONS. THE PATIENT WAS AN ELDERLY FEMALE, DIABETES MELLITUS, 3-VESSEL CORONARY ARTERY DISEASE, WITH SEVERE AORTIC STENOSIS REQUIRING INTERVENTION. HER COURSE WAS COMPLICATED BY LOW CARDIAC OUTPUT AND CARDIOGENIC SHOCK REQUIRING INOTROPE SUPPORT AND THEN EMERGENT LVAD INSERTION, TRICUSPID VALVE REPAIR, AORTIC VALVE REPAIR AND PATENT FORAMEN OVALE CLOSURE AROUND 3-MONTHS PRIOR TO THE TRANSPLANT. THE PATIENT UNDERWENT ORTHOTOPIC HEART TRANSPLANT AND EXPLANTATION OF HER LVAD ON (B)(6) 2024. INTRAOPERATIVELY, SHE WAS SEVERELY VASOPLEGIC, REQUIRING HIGH DOSE VASOPRESSORS AND INOTROPY. IN ADDITION, SHE REQUIRED TO METHYLENE BLUE AND CYANOKIT. A COMBINATION OF SEVERE VASOPLEGIA, MODERATE CARDIAC DYSFUNCTION, AND OLIGURIA PROMPTED THE PLACEMENT OF AN INTRA-AORTIC BALLOON PUMP AT BEDSIDE. SHE REQUIRED CENTRAL VENO-ARTERIAL ECMO ON (B)(6) 2024. HER HEMODYNAMICS THEN GRADUALLY IMPROVED SO HEMODYNAMIC SUPPORT WAS WEANED DOWN. ON (B)(6) 2024, CENTRAL VA ECMO WAS DECANNULATED, IABP WAS REMOVED ON (B)(6) 2024 AND PATIENT WAS EXTUBATED ON (B)(6) 2024. ON (B)(6) 2024, PATIENT ASPIRATED SECONDARY TO AN EPISODE OF EMESIS. SHE DEVELOPED ASPIRATION PNEUMONITIS WHICH LED TO WITHDRAWAL OF CARE BY THE FAMILY AND HER DEMISE. THE CAUSE OF DEATH WAS RESPIRATORY FAILURE SECONDARY TO ACUTE RESPIRATORY DISTRESS SYNDROME. THE PATIENT'S DEATH IS UNLIKELY TO BE CAUSED BY THE OCS DEVICE ISSUE, SINCE THE CAUSE OF DEATH WAS RESPIRATORY FAILURE, DUE TO ASPIRATION PNEUMONITIS AND ARDS. AFTER THE IMMEDIATE POST-OP PERIOD, THE CARDIAC FUNCTION WAS GOOD, GIVEN THAT ALL MECHANICAL SUPPORT WERE REMOVED, AND PATIENT WAS EXTUBATED AROUND A WEEK AFTER TRANSPLANTATION. THE POST-OP ADVERSE EVENTS EXPERIENCED BY THIS PATIENT ARE WELL DOCUMENTED COMPLICATIONS ASSOCIATED WITH TRANSPLANT PROCEDURES, PARTICULARLY FOR LVAD PATIENTS AND ARE NOT SUSPECTED TO BE RELATED TO THE OCS DEVICE.