BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 229665 · Received June 28, 1999

    Report

    Report Number
    MW1016630
    Event Type
    Malfunction
    Date Received
    June 28, 1999
    Date of Event
    June 21, 1999
    Report Date
    June 21, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV PUMP TOTAL VOLUME CLEARED. RATE SET AT 1CC/HR, VOLUME TO BE INFUSED SET AT 1CC. AFTER 30 MIN PUMP BEEPED DOSE COMPLETE AND TOTAL VOLUME READ 1CC. PUMP STOPPED AND SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT IV PUMP FRN ABBOTT LABORATORIES, INC. PLUM XL 52203HG01

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other 150ML BURETTE PUMP SET-01, LOT # 52203HG01.| LIFESHIELD LATEX-FREE PLUMSET MICRODRIP SOLUSET,