DIALOG PLUS

Description of Event or Problem

PATIENT DIED WHILE BEING TREATED ON DIALYSIS MACHINE. PATIENT WAS ELDERLY AND UNSTABLE, AND DEATH WAS UNRELATED TO THERAPY. ADDITIONAL INFORMATION PROVIDED BY THE NURSE MANAGER INDICATED THAT THE PATIENT EXPERIENCED A "SUDDEN DEATH SYNDROME" CAUSED BY FATAL CARDIAC ARRHYTHMIA DURING THE THERAPY. ALL VITALS WERE NORMAL AS PERIODICALLY CHECKED BY STAFF UP UNTIL THE TIME OF THE INCIDENT. THE PATIENT HAD A SEVERELY WEAK HEART, WAS DNR, SO NO CODE ACTION WAS TAKEN. THE FACILITY REQUESTED THAT NO FURTHER INSPECTION OF THE DIALYSIS MACHINE BY B. BRAUN IS NECESSARY AT THIS TIME.

Additional Manufacturer Narrative

IT APPEARS FROM THE EVENT DESCRIPTION AND THE ADDITIONAL INFORMATION PROVIDED BY THE FACILITY THAT THE MACHINE WAS NOT RELATED TO THE PATIENTS DEATH. HOWEVER, B. BRAUN IS REQUESTING A COPY OF THE TREND DISK FOR EVALUATION. IF ANY FURTHER INFORMATION BECOMES AVAILABLE THROUGH THE TREND DISK EVALUATION, A FOLLOW-UP REPORT WILL BE FILED.