BLUE SPRINGS
Received Jun 3, 1996 · Event occurred May 17, 1996
Report 34327 · MDR key 34327
Device
Product problems
- Reverse osmosis
- Material Rupture
Patient
66 YR
- Cardiac Arrest
- Death
Narrative
Description of Event or Problem
PT EXPIRED FOLLOWING MYOCARDIAL INFARCTION AND CARDIAC ARREST APPROX 90 MINS AFTER A HEMODIALYSIS TREATMENT. THE PT'S DIALYSIS WAS TERMINATED EARLY DUE TO A SUSPECTED PYROGEN REACTION. SUBSEQUENT INVESTIGATION INDICATES THAT THE REVERSE OSMOSIS SYSTEM (RO) USED TO TREAT THE WATER FOR REPROCESSING DIALYZERS HAD A RUPTURED MEMBRANE. REVERSE OSMOSIS PUMP HAD FAILED, AND PIECES OF THE BROKEN PUMP WERE FOUND IN THE RUPTURED REVERSE OSMOSIS MEMBRANE. IT IS UNKNOWN AS TO WHETHER THERE IS ANY ASSOCIATION BETWEEN THE SUSPECTED PYROGEN REACTION AND THE PT DEATH. SEVEN OTHER PTS ALSO EXPERIENCED SUSPECTED PYROGEN REACTIONS DURING THE SAME MORNING: SIX OF WHOM RECOVERED AND LEFT THE FACILITY THAT MORNING; THE SEVENTH PT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE NEXT DAY HAVING RECOVERED WITH NO INTERVENTION.