CELSIOR
Received Nov 11, 2002 · Event occurred Apr 25, 2002
Report 2950168-2002-00001 · MDR key 427284
Device
Generic name
Organ Preservation Solution
Manufacturer
Sangstat Medical CorpModel number
NACatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
48 YR
- Thrombosis
Narrative
Description of Event or Problem
PT UNDERWENT LIVER TRANSPLATATION IN 2002 DUE TO SUSPICION OF HEPATOCELLULAR CARCINOMA IN EXISTING ALCOHOLIC CIRRHOSIS (1998). THIS HEAVY SMOKER PT ALSO SUFFERED FROM HYPERTENSION AND BENIGN PAROXYSMAL POSITIONAL VERTIGO. IMMUNOSUPPRESSIVE TREATMENT INCLUDED TACROLIMUS AND STEROIDS. PRIOR TO TRANSPLATATION THE DONOR AND THE RECIPIENT WERE BOTH CMV POSITIVE. THE DONOR'S LIVER WAS RINSED IN-SITU AND EX-VIVO WITH CELSIOR, AND THEN COLD PRESERVED IN CELSIOR SOLUTION. DURING TRANSPLANTATION THE COLD ISCHEMIA TIME WAS 6 HOURS AND 19 MINUTES. THE PT RECEIVED PERI-OPERATIVE BLOOD TRANSFUSION. POST-TRANSPLANT EVOLUTION WAS FAVORABLE, WITHOUT COMPLICATION OR REJECTION. THE GRAFT FUNCTION WAS RAPIDLY REESTABLISHED WITH FACTOR V AT 100% ON D2. DOPPLER ULTRASONOGRAPHY PERFORMED ON D1 CONFIRMED THE ARTERIAL FLOW. AN INTRA-HEPATIC SEGMENTAL THROMBOSIS OF LEFT PORTAL BRANCH WAS SUSPECTED AND CONFIRMED BY CT SCAN. THE EVENT RESOLVED WITH HEPARIN. THE PT WAS DISCHARGED IN 2002. THE REPORTER ASSESSED THE EVENT AS POSSIBLY RELATED TO CELSIOR.