CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Description of Event or Problem

SEPTIC SHOCK DUE TO ENTEROBACTER CLOACAE [SEPTIC SHOCK]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHARMACIST REGARDING A (B)(6) FEMALE PATIENT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE (B)(6) 2013, THE LIVER AND KIDNEY FOR TRANSPLANT WERE PRESERVED WITH CELSIOR. IT WAS REPORTED THAT TOTAL 12 BAGS OF CELSIOR WERE USED. ON (B)(6) 2013, THE PT UNDERWENT LIVER AND KIDNEY TRANSPLANT. ON AN UNSPECIFIED DATE FOLLOWING THE TRANSPLANT, THE PT DEVELOPED THE LIFE-THREATENING EVENT OF SEPTIC SHOCK DUE TO ENTEROBACTER CLOACAE. THE OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FORT THE EVENT WAS ASSESSED AS SERVED. THE REPORTING PHARMACIST DID NOT PROVIDE THE CAUSAL RELATIONSHIP OF CELSIOR WITH THE EVENT. MANUFACTURER'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.