BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLUE SPRINGS

    MDR report key: 34327 · Received June 3, 1996

    Report

    Report Number
    34327
    Event Type
    Death
    Date Received
    June 3, 1996
    Date of Event
    May 17, 1996
    Report Date
    June 3, 1996
    Manufacturer
    BLUE SPRINGS CORP.
    Product Code
    JRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE SPRINGS REVERSE OSMOSIS SYSTEM JRS BLUE SPRINGS CORP. WP-280R

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death