CELSIOR

Description of Event or Problem

THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A NURSE. THIS CASE IS CROSS REFERRED TO (B)(4) (CLUSTER CASE). THIS CASE INVOLVES A PATIENT (DEMOGRAPHICS NOT PROVIDED) WHO DIED AFTER COMPLICATIONS FROM PSEUDOMONAS INFECTION WHOSE HEART WAS PRESERVED IN CELSIOR ORGAN PRESERVATION SOLUTION (CELSIOR). NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT'S HEART WAS PRESERVED IN CELSIOR, SOLUTION FOR ORGAN PRESERVATION (DOSE, FREQUENCY, ROUTE, LOT/BATCH NUMBER AND EXPIRATION DATE: NOT PROVIDED) FOR ORGAN PRESERVATION WHILST UNDERGOING HEART TRANSPLANT. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED PSEUDOMONAS INFECTION. ON AN UNKNOWN DATE, PATIENT DIED AFTER COMPLICATIONS OF PSEUDOMONAS INFECTION. IT WAS UNKNOWN WHEN THE AUTOPSY WAS PERFORMED. NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: FATAL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME. SERIOUSNESS CRITERIA: DIES AFTER COMPLICATIONS FROM PSEUDOMONAS INFECTION: SERIOUS (DEATH).

Additional Manufacturer Narrative

PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATE (B)(4) 2014: IN THIS CASE THE CAUSAL ROLE OF THE SUSPECT CELSIOR ORGAN PRESERVATION SOLUTION CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT OF FATAL EVENT OF COMPLICATIONS FROM PSEUDOMONAS INFECTION, HOWEVER, THE LACK OF INFORMATION REGARDING THE UNDERLYING MEDICAL HISTORY, CONCOMITANT MEDICATIONS USED BY THE PATIENT PRECLUDES THE COMPLETE CASE ASSESSMENT, MOREOVER, THE FURTHER LACK OF INFORMATION REGARDING THE AUTOPSY DETAILS OF THE PATIENT PRECLUDES THE COMPLETE AND COMPREHENSIVE CASE ASSESSMENT.