BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT

    MDR report key: 119668 · Received September 15, 1997

    Report

    Report Number
    MW1012081
    Event Type
    Other
    Date Received
    September 15, 1997
    Date of Event
    May 30, 1997
    Report Date
    July 21, 1997
    Manufacturer
    ABBOTT LABS
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER ERROR. CAREGIVER SET HEPARIN PUMP TO A DESIGNATED FLOW RATE. LATER THAT SHIFT THEY NOTICED THE FLOW RATE WAS MUCH TOO FAST. THERE WAS NO SERIOUS INJURY TO THE PT. THE PUMP WAS CHECKED BY INTERNAL BIOMED DEPT AND CO REP. NO PROBLEM WITH THE PUMP WAS FOUND. THEREFORE, IT WAS HYPOTHESIZED THAT THE CAREGIVER SET THE "TOTAL VOLUME" RATHER THAN THE "FLOW RATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INFUSION PUMP FRN ABBOTT LABS XL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other