D
Patient 1
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).