BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXA EXACTAMIX 1200

    MDR report key: 2386598 · Received December 16, 2011

    Report

    Report Number
    MW5023526
    Event Type
    Death
    Date Received
    December 16, 2011
    Date of Event
    December 4, 2011
    Report Date
    December 16, 2011
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFORMED AN INTERNAL CHART REVIEW BECAUSE PT'S DEATH WAS NOT EXPECTED AND THE SUDDEN DETERIORATION IN THIS PT'S CONDITION REVEALED AN ERROR THAT AN INCORRECT DOSING OF ELECTROLYTES RESULTING IN ELECTROLYTE ABNORMALITIES SEVERE ENOUGH TO CAUSE DEATH. INTERNAL INVESTIGATION REVEALED DATA WAS INCORRECTLY ENTERED INTO THE COMPOUNDING MACHINE. THE RATE FIELD CONSISTS OF THE VALUE, NUMERATOR AND DENOMINATOR. THE ERROR WAS MADE IN THE DENOMINATOR FIELD, WHERE THE DROP DOWN SELECTION WAS CHANGED FROM THE DEFAULT OF /HOUR TO /KG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXA EXACTAMIX 1200 COMPOUNDING SYSTEM NEP 2400-M
    2 ABACUS VERSION 2 ABACUS SE SOFTWARE USED WITH THE COMPOUNDING MACHINE LNX 4XY9396A70C5B302A70D

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Death