CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Description of Event or Problem

AFTER DE-CLAMPING, HEART DID NOT RESTART SPONTANEOUSLY [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED FROM A SURGEON ON (B)(6) 2011 REGARDING 4 UNSPECIFIED HEART TRANSPLANT PTS, INITIALS NOT PROVIDED. CELSIOR ADMINISTRATION INFO WAS NOT PROVIDED. PT HISTORY WAS NOT REPORTED. THE SURGEON REPORTED THAT IN 5 PTS THE TRANSPLANTED HEART DID NOT RESTART SPONTANEOUSLY AFTER DE-CLAMPING. IN 2 OF THE PTS THE HEART RESTARTED AFTER DRUG ADMINISTRATION. ONE RESTARTED AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), ONE PT DIED, AND THE LAST PT WAS ON ECMO AT THE TIME OF THIS REPORT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. INTENSITY WAS NOT PROVIDED. CAUSAL RELATIONSHIP TO THYMOGLOBULIN WAS CONSIDERED POSSIBLY RELATED. 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). MFR'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFO HAS BEEN REQUESTED.