CELSIOR

Description of Event or Problem

CELSIOR WAS USED FOR FLUSHING AND STORAGE OF A HEART WHICH WAS HARVESTED AND TRANSPLANTED THE SAME DAY. UPON TRANSPLANTION INTO THE RECIPIENT, THE HEART DEMONSTRATED PRIMARY GRAFT FAILURE. THE RECIPIENT, ALSO SUFFERS FROM PULMONARY HYPERTENSION. PRIOR TO THE TRANSPLANTATION, THEY WERE TREATED WITH NITROGLYCERIN AND HAD A BAD REACTION TO THE DRUG. AFTER THE HEART TRANSPLANTATION, THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THEIR CARDIAC INDEX =3, AFTER 5 MINUTES CARDIAC INDEX DETERIORATED TO 1, AND 1 HOUR LATER THE PT HAD A CARDIAC ARREST. THE PT RETURNED TO THE OPERATING ROOM AND IS CURRENTLY ON ECMO. THE COLD TIME FOR THE HEART IS APPROXIMATELY 4 HOURS. SINCE THEN THE PT NEUROLOGICAL STATUS HAS DETERIORATED. ONE LITER OF CELSIOR WAS USED TO PERFUSE THE HEART. THE FAMILY HAS REQUESTED REMOVAL OF LIFE SUPPORT, AND THE PT EXPIRED. ALSO, A FRESH BAG OF CELSIOR FROM THE SAME LOT (CE044-2) 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. SANGSTAT TESTED THE PH OF BOTH THE CELSIOR RETAIN SAMPLE AND A FRESH BAG OF CELSIOR FROM ORGAN PROCUREMENT FROM THE SUSPECT LOT# (CE044-2). BOTH BAGS 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 FROM HOSP WAS OBTAINED FROM A FRESH BAG OF CELSIOR IMMEDIATELY TESTED ON A BLOOD-GAS MACHINE.