CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Description of Event or Problem

NO MECHANICAL NOR ELECTRICAL ACTIVITY OF THE GRAFT [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED FROM A SURGEON ON (B)(6) 2011 REGARDING A (B)(6) FEMALE HEART TRANSPLANT PATIENT, INITIALS (B)(6). CELSIOR WAS GIVEN ONCE FOR ORGAN PRESERVATION ON (B)(6) 2011. PATIENT HISTORY WAS NOT REPORTED. ON (B)(6) 2011, THE DAY OF CELSIOR ADMINISTRATION, AFTER HEART TRANSPLANTATION AND AT THE END OF ANASTOMOSIS THERE WAS NO MECHANICAL NOR ELECTRICAL ACTIVITY OF THE GRAFT. BOTH BIOPSY AND CROSS MATCH TESTING WAS NEGATIVE. CONCOMITANT MEDICATIONS REPORTED WERE ATG FRESENIUS (ANTITHYMOCYTE IMMUNOGLOBULIN), SOLU MEDROL (METHYLPREDNISOLONE SODIUMSUCCINATE), ANTRA (OMEPRAZOLE SODIUM), AND AUGMENTIN (AMOXICILLIN). IT WAS THE OPINION OF THE SURGEON THAT THE EVENT WAS SEVERE IN INTENSITY AND POSSIBLY RELATED TO CELSIOR. THIS IS 1 OF 5 REPORTS FROM THIS SURGEON OF HEART GRAFT DYSFUNCTION AFTER TRANSPLANTATION. THIS IS 1 OF 5 REPORTS OF HEART GRAFT DYSFUNCTION FROM THIS SURGEON. THE COMPLETE LIST OF CASES CREATED FROM THIS REPORT INCLUDE (B)(4). NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.