CELSIOR

Description of Event or Problem

A PT UNDERWENT FIRST LIVER TRANSPLANTATION IN 2002 DUE TO SUSPICION OF HEPATOCELLULAR CARCINOMA IN EXISTING ALCOHOLIC CIRRHOSIS. THE DONOR'S LIVER WAS RINSED IN-SITU AND EX-VIVO WITH CELSIOR, AND THEN COLD PRESERVED IN CELSIOR SOLUTION. INFO ON DONOR AND GRAFT WAS NOT AVAILABLE. THREE MONTHS LATER, DUE TO THE NON-RESTORATION OF PRIMARY GRAFT FUNCTION (CAUSE NOT IDENTIFIED), THE DECISION WAS TAKEN TO PERFORM A SECOND TRANSPLANTATION. THE PT UNDERWENT URGENT SECOND LIVER TRANSPLANTATION 2 MONTHS LATER. FOR SECOND TRANSPLANTATION THE SOLUTION USED FOR ORGAN PRESERVATION WAS VIASPAN. DESPITE A FAVOURABLE EVOLUTION OF SECOND TRANSPLANTATION, THE PT EXPERIENCED POST-OPERATIVE COMPLICATIONS: PT DEVELOPED PULMONARY ASPERGILLOSIS AND SEPSIS DUE TO MULTIRESISTANT STAPHYLOCOCCUS, THEN RIGHT INTRA-CRANIAL FRONTOPARIETAL HEMATOMA. THE PT DIED IN 2002. THE REPORTER ASSESSED THE EVENT AS POSSIBLY RELATED TO CELSIOR, SPECIFYING THAT THERE WAS A POSSIBLE INDIRECT CAUSAL RELATIONSHIP BECAUSE FOLLOWING THE NON-RESTORATION OF PRIMARY GRAFT FUNCTION, THE PT HAS HAD TO BE RETRANSPLANTED IN A SHORT TIMEFRAME, WHICH LED TO AN UNSTABLE PERIOD IN INTENSIVE CARE UNIT WITH NOSOCOMIAL COMPLICATIONS. REPORT ORIGINATED FROM AN INVESTIGATOR-INITIATED STUDY TITLED "ASSESSMENT OF CELSIOR IN LIVER GRAFT PRESERVATION".