BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+

    MDR report key: 524428 · Received February 16, 2004

    Report

    Report Number
    2921482-2004-00077
    Event Type
    Other
    Date Received
    February 16, 2004
    Date of Event
    January 6, 2004
    Report Date
    January 21, 2004
    Manufacturer
    ABBOTT LABS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNDERDELIVERY. THE CUSTOMER CONTACT INDICATED THAT THE EVENT WAS THE RESULT IN AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. AT 1630, THE PUMP WAS DELIVERING 20GM OF METHOTRXATE IN 1000ML AT A RATE OF 62.5ML/HR INSTEAD OF THE PHYSICIAN ORDERED RATE OF 250ML/HR OVER 4 HOURS. AFTER AN UNSPECIFIED TIME, THE ERROR WAS NOTED AND THE PUMP WAS REPROGRAMMED TO DELIVER AT THE INTENDED RATE. THERE WERE NO REOPRTED ADVERSE PATIENT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other PLUM A+ SOFTWARE MODULE, LIST # 12393.