CELSIOR

Description of Event or Problem

CELSIOR WAS USED FOR FLUSHING AND STORAGE OF A HEART WHICH WAS HARVESTED AND TRANSPLANTED THE NEXT DAY. UPON TRANSPLANTATION INTO THE RECIPIENT, THE HEART DEMONSTRATED PRIMARY GRAFT FAILURE. WITHIN 6 HOURS AFTER HEART TRANSPLANTATION, THE PT RETURNED TO THE OPERATING ROOM FOR BLEEDING COMPLICATIONS. THE COLD TIME FOR THE HEART IS APPROXIMATELY 2 HOURS. THE PT IS CURRENTLY ON ECMO. THE PT HAD IMMEDIATE GRAFT DYSFUNCTION. THE TRANSPLANTED ORGAN WAS FROM A DONOR WITH SOME CORONARY ARTERY DISEASE AND A HISTORY OF COCAINE USE. THE RECIPIENT ALSO EXHIBITED AN ATYPICAL RESPONSE TO VASODILATORS (NITROGLYCERIN, NITROPRUSSIDE) AFTER THE TRANSPLANTED HEART. THE PT MAY ALSO HAVE HAD A DEGREE OF PULMONARY HYPERTENSION. CURRENTLY, THE PT IS OFF ECMO, AND A NEW DONOR HEART HAS NOT YET BEEN IDENTIFIED. ONE LITER OF CELSIOR WAS USED TO PERFUSE THE HEART. THE HEART HAS CURRENTLY REGAINED FUNCTION DESPITE THE HISTORY OF ORGAN DONOR DRUG ABUSE AND CORONARY ARTERY DISEASE. THE PT IS BACK ON THE TRANSPLANT LIST FOR A NEW ORGAN. ALSO, A FRESH BAG OF CELSIOR FROM THE SAME LOT WAS TESTED BY THE INSTITUTION AND WAS FOUND TO HAVE A PH OF 6.95. THE PH NORMAL FOR CELSIOR IS 7.3 +/- 0.1. THE PULMONARY HYPERTENSION IS NOW UNDER CONTROL. THE PH TESTING OF BOTH THE CELSIOR RETAIN SAMPLE AND A FRESH BAG OF CELSIOR FROM ORGAN PROCUREMENT FROM THE SUSPECT LOT # SHOWED A PH OF 7.2. THIS IS WITHIN THE SPECIFICATION OF CELSIOR. THE PREDISPOSING DIAGNOSIS FOR THE TRANSPLANT WAS ISCHEMIC DILATED CARDIOMYOPATHY. ALSO, THE PH OF 6.95 WAS OBTAINED FROM A FRESH BAG OF CELSIOR IMMEDIATELY TESTED ON A BLOOD-GAS MACHINE.