BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER DIAGNOSTICS

    MDR report key: 259826 · Received January 24, 2000

    Report

    Report Number
    259826
    Event Type
    Malfunction
    Date Received
    January 24, 2000
    Date of Event
    January 16, 2000
    Report Date
    January 24, 2000
    Manufacturer
    DADE BEHRING, INC. (BAXTER DIAGNOSTICS)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TO PCU FROM EMERGENCY DEPT WITH IV HEPARIN RUNNING AT 20CC/HOUR. BAG NOTED HALF FULL. AFTER PRIMARY ASSESSMENT OF BAG, NOTED TO HAVE 400CC GONE. PUMP RECHECKED AND SETTING AT 20CC HOUR. PUMP FOUND TO BE INFUSING AT APPROX 200CC HOUR. PUMP STOPPED AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER DIAGNOSTICS IV PUMP FRN DADE BEHRING, INC. (BAXTER DIAGNOSTICS) FLO-GARD 6301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other