BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+

    MDR report key: 524399 · Received February 12, 2004

    Report

    Report Number
    2921482-2004-00064
    Event Type
    Other
    Date Received
    February 12, 2004
    Date of Event
    January 12, 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 OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. IN 2004 AT 1900, THE PUMP WAS PROGRAMMED TO DELIVER 25000 UNITS OF HEPARIN IN 250ML AT A RATE OF 0.1ML/HR INSTEAD OF THE INTENDED RATE OF 11 ML/HR. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE ERROR WAS NOTED AND THE THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED 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 UNKNOWN Other PLUM A+ SOFTWARE MODULE, LIST# 12393.