BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 492190 · Received October 28, 2003

    Report

    Report Number
    492190
    Event Type
    Malfunction
    Date Received
    October 28, 2003
    Date of Event
    September 27, 2003
    Report Date
    October 6, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    100CC 0.9NS WITH 100MG CARDIZEM STARTED IV ON ABBOTT PUMP SET AT 10 CC/HOUR. SOLUTION BAG NOTED EMPTY 2 HOURS AND 15 MINUTES LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT IV PUMP FRN ABBOTT LABORATORIES 27182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IV TUBING| ADD-VANTAGE UNIT (ABBOTT).| 100CC 0.9NS IV SOLUTION BAG (ABBOTT)