CELSIOR
Received Jan 3, 2006
Report 2950168-2005-00004 · MDR key 660315
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 WHOLE LIVER GRAFT TRANSPLANT PATIENT. THIS IS THE SECOND PATIENT OUT OF 7 PATIENTS THAT EXPERIENCED HEPATIC ARTERIAL THROMBOSIS (HAT) MENTIONED IN THIS ARTICAL. THREE UNSPECIFIED PATIENTS OUT OF THESE 7 PATIENTS DIED. THE TRANSPLANTED LIVER WAS COLD PRESERVED WITH CELSIOR AS PART OF THE TRANSPLANTATION PROCUREMENT. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNKNOWN DATE, AFTER TRANSPLANT, THE PATIENT EXPERIENCED HEPATIC ARTER THROMBOSIS. THE PATIENT'S RISK FACTORS FOR THE THROMBOSIS INCLUDED EXTENSIVE ARTERIOSCLEROSIS, GRAFT HEPATIC ARTERY IMPLANTED ON RECIPIENT ATHEROMATOUS SPLENIC ARTERY. THE COLD ISCHEMIC TIME WAS 12 HOURS 40 MINUTES. SUBSEQUENT TO THE FIRST HEPATIC ARTERY THROMBOSIS, THE PATIENT UNDERWENT A SECOND LIVER TRANSPLANT AND EXPERIENCED A SECOND HEPATIC ARTERY THROMBOSIS. THE PATIENT'S RISK FACTORS INCLUDED RETRANSPLANTATION FOR HEPATIC ARTERY THROMBOSIS AND HEPATIC ARTERY WAS IMPLANTED ON RECIPIENT ILIAC ARTERY. THE COLD ISCHEMIC TIME WAS 9 HOURS. THE LIVER GRAFT WAS FLUSHED WITH 500 ML OF COLD (4 DEGREES CELSIUS) 4 % HUMAN ALBUMIN VIA THE PORTAL VEIN IMMEDIALTELY BEFORE REVASCULARIZATION. THE PATIENT'S CLINICAL OUTCOME IS UNKNOWN. 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 2 OF 7. NO SAMPLE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED BY THE USER FACILITY, THERFORE, COMPANY QUALITY ASSURANCE IS CURRENTLY UNABLE TO PERFORM AN EVALUATION OR LOT HISTORY REVIEW. IF A LOT NUMBER IS PROVIDED IN THE FURTURE, THIS COMPLAINT WILL BE RE-OPENED AND THE APPROPRIATE INVESTIGATION WILL BE CONDUCTED.