CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Description of Event or Problem

ACUTE GRAFT FAILURE [GRAFT DYSFUNCTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A HEALTH PROFESSIONAL REGARDING AN UNSPECIFIED TRANSPLANT PT, INITIALS NOT REPORTED. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INDICATED CELSIOR SOLUTION FOR ORGAN PRESERVATION, DOSE REGIMEN NOT PROVIDED. ON AN UNK DATE, TIME AFTER CELSIOR NOT REPORTED, 2 PTS HAD ACUTE GRAFT FAILURE AFTER THIS LOT OF CELSIOR WAS USED. THIS LOT WAS USED IN A TOTAL OF 3 PTS. THE OUTCOME FOR THE EVENT OF ACUTE GRAFT FAILURE WAS UNK. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY AND CAUSAL RELATIONSHIP OF THE EVENT TO CELSIOR WERE NOT PROVIDED. THIS IS 1 OF 2 CASES CREATED FOR THIS REPORTED INFO. PLEASE REFER TO CELS-1000025 FOR THE OTHER CASE.

Additional Manufacturer Narrative

MFR'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFO HAS BEEN REQUESTED.