BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS TPN SOFTWARE

    MDR report key: 5795224 · Received July 11, 2016

    Report

    Report Number
    MW5063393
    Event Type
    Other
    Date Received
    July 11, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 11, 2016
    Manufacturer
    BAXTER
    Product Code
    NEP
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    (B)(6) PTS (26 PEDIATRIC, 21 ADULT) RECEIVED X 4 MAGNESIUM SULFATE DOSES COMPOUNDED IN THEIR TPN BECAUSE OF A NEW DILUTED MAGNESIUM SULFATE FILE ADDED TO OUR BAXTER ABACUS TPN SOFTWARE UNINTENDED TO GO LIVE BUT WAS CREATED FOR INITIAL TESTING. THE DILUTED FILE WAS CREATED ON (B)(6), AND THE COMPOUND USED THAT FILE FOR 24 HR TPN BAGS PUMPED ON (B)(6) RESULTING IN X 4 DOSES ABOVE ORDERS. THE SOFTWARE ALLOWED THE SAME NDC TO BE ENTERED FOR THE CURRENT MAG SULFATE FILE AS WELL AS THE NEW DILUTED MAG SULFATE FILE. THE SOFTWARE ALSO DEFAULTS TO HAVE THE "UNAVAILABLE" OPTION BOX UNCHECKED. THE PHARMACIST ADDING THE NEW FILE DID NOT REALIZE THAT THIS BOXED NEEDED TO BE CHECKED TO PREVENT THE FILE FROM POTENTIALLY GOING LIVE. WE IN CONTACT WITH BAXTER REGARDING THE EVENT. WE HAVE ALSO CONTACTED (B)(4) TO REPORT THE EVENT AND FORWARDED SOFTWARE SCREENSHOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437675 ABACUS TPN SOFTWARE ABACUS TPN SOFTWARE NEP BAXTER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other