BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+

    MDR report key: 614824 · Received July 22, 2004

    Report

    Report Number
    2921482-2004-00429
    Event Type
    Other
    Date Received
    July 22, 2004
    Date of Event
    June 25, 2004
    Report Date
    July 8, 2004
    Manufacturer
    HOSPIRA, INC.
    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

    REPORT RECEIVED OF AN OVERDELIVERY. THE CUSTOMER CONTACT INDICATED THAT THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. IN 2004, THE PUMP WAS DELIVERING AN UNSPECIFIED DRUG ON LINE B AT A RATE OF 56 ML/HR. AT 2149, THE NURSE PROGRAMMED LINE A OF THE PUMP TO DELIVER HEPARIN 1U/1ML AT A RATE OF 56 ML/HR INSTEAD OF THE INTENDED RATE OF 1ML/HR. REPORTEDLY, THE NURSE NOTED THAT THE VOLUME INFUSED VALUE OF THE PUMP DISPLAY WAS "TOO HIGH OF A NUMBER." THE PHYSICIAN WAS NOTIFIED AND THE INFUSION WAS TUNED OFF. THE PUMP WAS REMOVED FROM CLINICAL SERVICE AND THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ INFUSION PUMP FPA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other