BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOMIX 3+3/AS COMPOUNDER

    MDR report key: 477085 · Received July 31, 2003

    Report

    Report Number
    6000001-2003-08628
    Event Type
    Other
    Date Received
    July 31, 2003
    Date of Event
    July 4, 2003
    Report Date
    July 7, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHARMACY ATTEMPTED TO RUN 10% DEXTROSE ON ONE OF THE FREE STATIONS IN AN ATTEMPT TO COMPOUND A TPN THAT WAS TO CONTAIN 12.5% DEXTROSE, BUT WERE UNABLE TO DO SO. THE PHARMACY TECHNICIAN THOUGHT 10% DEXTROSE SOLUTION WAS HUNG ON THE 70% DEXTROSE STATION. THE PHARMACY REPORTED THAT THE SPECIFIC GRAVITY WAS CHANGED TO THE 10% DEXTROSE SG, HOWEVER, 70% DEXTROSE WAS HUNG IN ERROR. THE TPN WAS DISPENSED TO A PATIENT. THE PATIENT EXPERIENCED A DROP IN THE SERUM BLOOD GLUCOSE LEVEL, BUT DID NOT REQUIRE MEDICAL INTERVENTION AS THE DROP IN THE BLOOD SUGAR LEVEL WAS NOTICED IMMEDIATELY BY A CLINICIAN. THE PHARMACY REPORTS THAT THE TPN WAS ANALYZED BY THE BLOOD CHEMISTRY LAB AND IT WAS FOUND THAT THE SOLUTION CONTAINED ONLY 10% DEXTROSE. THE DIRECTOR OF PHARMACY STATED THAT SHE HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION TO EXPLAIN THE DISCREPANCY, BUT HAS NOT BEEN ABLE TO OBTAIN ENOUGH INFORMATION TO EXPLAIN THE SEQUENCE OF EVENTS ADEQUATELY. THE PATIENT RECOVERED WITH NO SEQUEALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMIX 3+3/AS COMPOUNDER I.V. SOLUTION COMPOUNDER LHI BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN