inforMED
DeathJRS

BLUE SPRINGS

Received Jun 3, 1996 · Event occurred May 17, 1996

Report 34327 · MDR key 34327

Device

Generic name

Reverse Osmosis System

Manufacturer

Blue Springs Corp.

Model number

WP-280R

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.