CELSIOR
Received Jan 3, 2006
Report 2950168-2005-00006 · MDR key 660015
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
48 YR
Narrative
Description of Event or Problem
THE LITERATURE DESCRIBES A PT WHOLE LIVER GRAFT TRANSPLANT PT. THIS IS THE FOURTH PT OUT OF THE 7 PTS THAT EXPERIENCED HEPATIC ARTERIAL TRHOMBOSIS (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 DID NOT HAVE ANY RISK FACTORS FOR THE THROMBOSIS. THE COLD ISCHEMIC TIME WAS 5 HOURS 10 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 CLINICAL 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 4 OF 7. NO SAMPLE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED BY THE USER FACILITY, THEREFORE, CO QA IS CURRENTLY UNABLE TO PERFORM AN EVAL OR LOT HISTORY REVIEW.