BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERLAKE CONTINENTAL WATER SYSTEMS

    MDR report key: 11755 · Received December 14, 1993

    Report

    Report Number
    11755
    Event Type
    Death
    Date Received
    December 14, 1993
    Date of Event
    July 16, 1993
    Report Date
    September 10, 1993
    Manufacturer
    INTERLAKE CONTINENTAL WATER SYSTEMS
    Product Code
    FIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE PTS DIED WITHIN SEVERAL HRS AFTER COMPLETING OUTPT DIALYSIS TREATMENT. SUBSEQUENT INVESTIGATIONS REVEALED THAT THE DEIONIZATION TANKS THROUGH WHICH THE WATER FOR DIALYSIS WAS PROCESSED FAILED TO OPERATE PROPERLY, THEREBY EXPOSING THESE PTS TO EXCESSIVE LEVELS OF FLUORIDE. IT IS BELIEVED THESE PTS DIED OF FLUORIDE INTOXICATION. PT'S AGES: 81, 56 AND 78. ADD'L MODEL NOS: 3042209, 070193 AND 06020393.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLAKE CONTINENTAL WATER SYSTEMS DEIONIZATION TANK FIP INTERLAKE CONTINENTAL WATER SYSTEMS 93060231, 93060230, 3042211

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death CHLORIDE, ACTRIL, RENALIN, SODIUM CHLORIDE, ACID| PTS.| OF THESE MAY HAVE BEEN USED ON THE THREE DECEASED| COBE CENTRY SYSTEM 3. DIALYSIS MACHINES (SOME OR| POTASSIUM CHLORIDE, AQUEOUS SOLUTION, CALCIUM| CONCENTRATE POWDER FOR BICARBONATE DIALYSATE,| CONCENTRATION FOR BICARBONATE DIALYSATE, HEPARIN,E