BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+

    MDR report key: 506682 · Received January 14, 2004

    Report

    Report Number
    2921482-2004-00017
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 15, 2003
    Report Date
    December 18, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN OVERDELIVERY. THE CUSTOMER CONTACT INDICATED THAT THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE PUMP WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER 100MCG OF PHENYLEPHRINE IN 1ML INSTEAD OF THE INTENDED CONCENTRATION OF 10MCG IN 100ML. IN ADDITION, THE PUMP WAS PROGRAMMED TO DELIVER A DOSE OF 405MCG/KG/MIN INSTEAD OF THE INTENDED DOSE OF 4.5MCG/KG/MIN. AT 0015 IN 12/2003, THE NURSE NOTED THE BAG WAS EMPTY AND THE PATIENT EXPERIENCED "BLOOD PRESSURE IN THE 120'S" AND "HEART RATE DROP". THE PATIENT WAS TREATED WITH UNSPECIFIED BOLUS DOSES OF PHENYLEPHRINE UNTIL THE PATIENT WAS STABLE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 35 DAY Required Intervention PLUM A+ SOFTWARE MODULE, LIST #12393.