CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION
Received Jan 3, 2012
Report 2950168-2012-00001 · MDR key 2404297
Device
Generic name
None
Manufacturer
Genzyme Polyclonials S.a.s.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Cardiac Arrest
Narrative
Description of Event or Problem
AFTER DE-CLAMPING, HEART DIDN'T RESTART SPONTANEOUSLY [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED FROM A SURGEON ON (B)(6) 2011 REGARDING 4 UNSPECIFIED HEART TRANSPLANT PATIENTS, INITIALS NOT PROVIDED. CELSIOR ADMINISTRATION INFORMATION WAS NOT PROVIDED. PATIENT HISTORY WAS NOT REPORTED. THE SURGEON REPORTED THAT IN 5 PATIENTS THE TRANSPLANTED HEART DID NOT RESTART SPONTANEOUSLY AFTER DE-CLAMPING. IN 2 OF THE PATIENTS THE HEART RESTARTED AFTER DRUG ADMINISTRATION, 1 RESTARTED AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), 1 PATIENT DIED, AND THE LAST PATIENT 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. THE COMPLETE LIST OF CASES CREATED FROM THIS REPORT INCLUDE (B)(4).
Additional Manufacturer Narrative
NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.