BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROMACRO 23 COMPOUNDER

    MDR report key: 969198 · Received December 26, 2007

    Report

    Report Number
    1419106-2007-00023
    Event Type
    Death
    Date Received
    December 26, 2007
    Date of Event
    November 3, 2005
    Report Date
    November 7, 2005
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATELY AFTER BEING CONTACTED BY THE CUSTOMER, BAXA REPRESENTATIVE PERFORMED A SITE VISIT FOR AN INVESTIGATION IN CONJUNCTION WITH THE FACILITY; A REVIEW OF PAPER AND ELECTRONIC DATA WAS PERFORMED. UPON REVIEW OF THE INFORMATION GENERATED BY THE COMPOUNDER, IT WAS NOTED THAT ALL ORDERS WERE COMPLETELY CORRECTLY AND ACCURATELY. THE POTASSIUM CAME FROM TWO SOURCES (KCL: 20.0 MEQ/L AND KPC4: 17.6 MEQ/L) AND WAS ORDERED AT 37.6 MEQ/L; TESTING DETERMINED THAT 37.4 MEQ/L WAS DELIVERED. IN ADDITION, SUBSEQUENT TESTING WAS PERFORMED ON THE PATIENT'S POTASSIUM FLUID CONCENTRATION; RESULTS REVEALED A POTASSIUM LEVEL OF 31 MEQ, WHICH IS WITHIN THE ACCEPTABLE LIMITS. THEREFORE, IT IS CONCLUDED THAT THE COMPOUNDER OPERATED AS DESIGNED DURING THIS INCIDENT.

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED RETROSPECTIVELY AFTER A REVIEW OF PRIOR COMPLAINT INFORMATION, THIS INCIDENT WAS DETERMINED TO BE REPORTABLE. IN 2005, BAXA WAS NOTIFIED THAT A PATIENT RECEIVING TPN THERAPY, COMPOUNDED ON THE MICROMACRO 23 COMPOUNDER, EXPIRED ON 11-04-2005. THE PATIENT'S PHYSICIAN CLAIMED THAT THE PATIENT RECEIVED 50% MORE POTASSIUM THAN PRESCRIBED. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE POTASSIUM VOLUME WAS AS ORDERED AND THE PHYSICIAN'S CLAIM WAS THE RESULT OF A CALCULATION ERROR ON THE PHYSICIAN'S PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMACRO 23 COMPOUNDER PHARMACY COMPOUNDING SYSTEM LHI BAXA CORP. 072R-RS232 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death