BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+

    MDR report key: 443785 · Received February 13, 2003

    Report

    Report Number
    2921482-2003-00071
    Event Type
    Other
    Date Received
    February 13, 2003
    Date of Event
    January 28, 2003
    Report Date
    January 28, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "PT WAS TO RECEIVED REGULAR INSULIN (100U IN 100CC) AT 1 CC/HR. THIS WAS TO RUN CONCOMITANTLY WITH MAINTNENCE IVF AT 100 CC/HR. THE INSULIN DRIP WAS STARTED AT 0900. AT APPROX 1145, IT WAS CHANGED TO ANOTHER PUMP AND THE RATE WAS INADVERTENTLY PROGRAMMED INCORRECTLY. AT 1222, THE BAG WAS FOUND TO BE EMPTY & THE ERROR IN RATE WAS NOTED. D10 WAS HUNG & SERIAL ACCUCHECKS WERE DONE." THE CUSTOMER WAS CONTACTED FOR FURTHER INFO. IT WAS REPORTED THAT AT APPROX 0900 WHILE THE PT WAS IN THE ER, THE PUMP WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER 1L OF 5% DEXTROSE & 1/2 NS AT A RATE OF 100 ML/HR ON LINE A. LINE B WAS PROGRAMMED TO DELIVER 100 UNITS OF INSULIN IN 100ML AT A RATE OF 1 ML/HR. THE PT WAS TRANSFERRED TO ANOTHER FLOOR & THE INFUSION WAS DISCONTINUED ON THE 1ST PUMP. A 2ND PUMP WAS OBTAINED & LINE A WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER AT A RATE OF 1 ML/HR INSTEAD OF THE INTENDED RATE OF 100 ML/HR. LINE B WAS PROGRAMMED TO DELIVER AT A RATE OF 100 ML/HR INSTEAD OF THE INTENDED RATE OF 1 ML/HR. APPROX 35 MINS LATER, THE PT COMPLAINED OF NAUSEA & DIZZINESS. AT THIS TIME, THE RN NOTED THAT THE "INSULIN CONTAINER WAS EMPTY" & DISCOVERED THE ERROR IN PROGRAMMING. THE PT WAS TREATED WITH 10% DEXTROSE AT AN UNSPECIFIED RATE FOR AN UNSPECIFIED LENGTH OF TIME. AT 1900, THE REGULAR INSULIN INFUSION WAS RESTARTED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ INFUSION PUMP FPA ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIFESHIELD PLUMSET, LIST #11943.| PLUM A+ SOFTWARE MODULE, LIST #12393.