BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABACUS TPN SOFTWARE

    MDR report key: 1272465 · Received December 11, 2008

    Report

    Report Number
    MW5009312
    Event Type
    Injury
    Date Received
    December 11, 2008
    Date of Event
    November 14, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BAXA CORPORATION
    Product Code
    LNX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SETTINGS IN THE BAXA ABACUS SOFTWARE VERSION 2.0 ALLOWED FOR AN OVER DELIVERY OF CALCIUM GLUCONATE IN THE COMPOUNDED TPN. THE REPORTED INCIDENT WAS DISCOVERED WHEN PERIPHERAL INTRAVENOUS SITES EXPERIENCED INFILTRATION. SERUM CALCIUM LEVELS WERE CHECKED AND FOUND TO BE HIGH. DATES OF USE: SEVEN MONTHS IN 2008. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS TPN SOFTWARE NONE LNX BAXA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability