CELSIOR
Received Jan 3, 2006
Report 2950168-2005-00003 · MDR key 659951
Device
Generic name
Organ Preservation Solution
Manufacturer
Federa Limoges Sas, Zi NordModel number
NICatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
55 YR
Narrative
Description of Event or Problem
THE LITERATURE DESCRIBES A PT WHOLE LIVER GRAFT TRANSPLANT PT. THIS IS THE FIRST PT OUT OF THE 7 PTS THAT EXPERIENCED HEPATIC ARTERIAL THROMBOSIS (HAT) MENTIONED IN THIS ARTICLE. THREE UNSPECIFIED PTS OUT OF THESE 7 PTS DIED. THE TRANSPLANTED LIVER WAS COLD PRESERVED WITH CELSIOR AS PART OF THE TRANSPLANTATION PROCUREMENT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNK DATE, AFTER TRANSPLANT, THE PT EXPERIENCED HEPATIC ARTERY THROMBOSIS. THE PT'S RISK FACTORS FOR THE THROMBOSIS INCLUDED RECIPIENT PORTAL VEIN THROMBOSIS AND HEPATIC ARTERY STENOSIS, DOUBLE HEPATIC ARTERY AND PORTAL VEIN JUMP POLYTETRAFLUOROETHYLENE VASCULAR GRAFT PROSTHESIS. THE COLD ISCHEMIC TIME WAS 10 HOURS 20 MINUTES. THE LIVER GRAFT WAS FLUSHED WITH 500 ML OF COLD (4 DEGREES CELSIUS) 4% HUMAN ALBUMIN VIA THE PORTAL VEIN IMMEDIATELY BEFORE REVASCULARIZATION. THE PT'S CLLINICAL OUTCOME IS UNK. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. IT WAS THE OPINION OF THE AUTHORS THAT ENDOTHELIAL INJURY LEADING TO THE EVENT OF HEPATIC ARTERY THROMBOSIS COULD NOT BE RULED OUT AND WAS POSSIBLY RELATED TO CELSIOR. THIS IS CASE REPORT 1 OF 7. NO SAMPLE WAS RETURNED AND NO LOT # WAS PROVIDED BY THE USER FACILITY, THEREFORE, CO QUALITY ASSURANCE IS CURRENTLY UNABLE TO PERFORM AN EVALUATION OR LOT HISTORY REVIEW.