BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABACUS VERSION 2 SOFTWARE

    MDR report key: 1000349 · Received February 18, 2008

    Report

    Report Number
    MW5005566
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BAXA
    Product Code
    LNX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RECEIVED CALL FROM THE HOSPITAL, ASKING IF AN ERROR IN COMPOUNDING HYDRATION COULD HAVE OCCURRED. PT'S MAGNESIUM LEVEL WAS 2.1 IN 2008, AND ON TWO DAYS LATER 9.1. THE ORDER WAS FOR D5/0.2 % SODIUM CHLORIDE WITH KPHOS 5MSQ/L + 1200 MG MGSO4/L AT 100 CC/HR CONTINUOUSLY. THE COMPOUNDER DID NOT RECOGNIZE THE MGSO4 AS A SALT AND CALCULATED THE MAGNESIUM AS AN ION. THE RESULTANT ERROR CAUSED AN OVER INFUSION OF MAGNESIUM 30GM/24HRS VS 2.8 GM/24HRS. THE INFUSION RAN FOR APPROXIMATELY 48 HRS BEFORE ERROR WAS CAUGHT. THE INFUSION WAS STOPPED AT CHILDRENS AND BY THE EVENING OF FOUR DAYS LATER, MG LEVEL WAS 3.1 AND BACK TO NORMAL ON THE SAME DAY. PATIENT WAS TO BE DISCHARGED THE SAME DAY, BUT DEVELOPED A FEVER WHICH WILL PROLONG HIS HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS VERSION 2 SOFTWARE BAXA MICRO/MACRO COMPOUNDER LNX BAXA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention MEDICATION INVOLVED MGSO4 4.06MSQ/ML OR 500M/ML