CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION
Received Dec 30, 2011
Report 2950168-2011-00001 · MDR key 2401092
Device
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Death
Narrative
Description of Event or Problem
AFTER DE-CLAMPING, HEART DIDN'T RESTART SPONTANEOUSLY [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D FROM A SURGEON ON (B)(6) 2011 REGARDING 5 UNSPECIFIED HEART TRANSPLANT PTS, INITIALS NOT PROVIDED. CELSIOR ADMINISTRATION 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, 1 RESTARTED AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), 1 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 POSSIBLE. THIS IS 1 OF 5 REPORTS OF HEART GRAFT DYSFUNCTION FROM THIS SURGEON. THIS CASE REFERS TO THE PT THAT DIED AFTER THE EVENT. THE COMPLETE LIST OF CASES CREATED FROM THIS REPORT INCLUDE (B)(4).
Additional Manufacturer Narrative
MFR'S COMMENT: NO FURTHER DETAILS WERE REC'D. FURTHER INFO HAS BEEN REQUESTED.