CELSIOR

Description of Event or Problem

AT AN UNSPECIFIED DATE, THE RECIPIENT DEVELOPED GRAFT VENOUS THROMBOSIS. FURTHER INFO HAS BEEN REQUESTED. ADDITIONAL INFO RECEIVED IN MAR 2005 FROM THE PHYSICIAN: PT WHO WAS ON A WAITING LIST FOR A LEFT KIDNEY TRANSPLANT. THIS PT HAD A MEDICAL HISTORY OR POLYCYSTIC KIDNEY DISEASE, HEMODIALYSIS SINCE AUGUST 2004 AND RIGHT KIDNEY TRANSPLANT. THE PROCEDURE WAS PERFORMED, ACCORDING TO A SCANDITRANSPLANT EXCHANGE PROGRAM. THE LEFT KIDNEY WAS REMVED FROM THE DONOR (NO DETAILS) AND PERFUSED WITH CELSIOR IN 2005. THE SURGEON WHO PERFORMED THE TRANSPLANT USED EURO-COLLINS SOLUTION FOR RE-PERFUSION OF THE OPEN. THE ORGAN WAS OBSERVED AND DID NOT SHOW ANY ABNORMALITY. THE OUTPUT FLUID WAS CLEAR AND NOTHING WAS NOTED TO BE UNSUSUAL IN THE REPERFUSION. IN THE TRANSPLANT OPERATION, THE REVASCULARISATION OR THE GRAFT WAS PERFECT AND THE OPERATION WAS UNEVENTFUL. THE PT WAS MOBILISED THE SAME DAY OF THE PROCEDURE. BEFORE THE TRANSPLANT PROCEDURE, THE PT RECEIVED ONE ORAL DOSE OF CYCLOPSORINE 5 MG/KG, THEN THIS DRUG WAS TEMPORARILY DISCONTINUED AND RESUMED AFTER THE TRANSPLANT. ON POST-OPERATIVE DAY 3, THE PT PRESENTED WITH AN OVERWEIGHT ALONG WITH THE ABSENCE OF CREATININE BLOOD LEVEL DECREASE AND REQUIRED HEMODIALYSIS. TWO DAYS LATER, WHEREAS THE PT HAD A GOOD DIURESIS, A DECREASE IN BLOOD LEVEL CREATININE AND A GOOD GENERAL STATE, THEY SUDDENLY EXPERIENCED PAIN IN THE WOUND WHILE THEY WAS SITTING WITH VISTORS. DOPPLER ULTRASOUND REVEALED BAD VENOUS FLOW AND WATERHAMMER LIKE ARTERIAL FLOW. THE PAIN INCREASED TREMENDOUSLY AND AN IMMEDIATE EXPLORATION SHOWED RUPTURED GRAFT WITH STILL ARTERIAL CIRCULATION BUT THROMBOSIS IN THE RENAL VEIN/ THE GRAFT WAS REMOVED. A PRELIMINARY EXAMINATION FOR A COAGULOPATHY HAS SO FAR NOT REVEALED SPECIFIC DISORDERS. DURING THE DAY OF TRANSPLANTECTOMY, THE PT'S ARTERIO-VENOUS FISTULA WAS ALSO THROMBOSED. THE PT RECOVERED WELL AFTER THEIR GRAFT REMOVAL AND WAS DISCHARGED FROM THE TRANSPLANT UNIT TO THEIR OWN HOSP THE 11TH DAY. DUE TO THE FACT THAT THE ANASTOMOSIS WAS PERFECT AND NO TECHNICAL REASON FOR VENOUS THROMBOSIS HAD BEEN FOUND, IT WAS THE REPORTER'S OPINION THAT THE EVENT COULD BE RELATED TO CELSIOR WHICH IS AN EXTRA-CELLULAR PRESERVATION SOLUTION. THE SPECIFIC BATCH NUMBER OF CELSIOR WHICH WAS USED DURING THIS PROCEDURE REMAINED UNK SINCE THE HOSP PHARMACIST HAD FOUR BATCH NUMBERS IN STOCK AT THAT TIME.