BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 376059 · Received February 1, 2002

    Report

    Report Number
    MW4003159
    Event Type
    Malfunction
    Date Received
    February 1, 2002
    Date of Event
    December 31, 2001
    Report Date
    January 10, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT 07:40, 250 CC OF 450MG AMIODARONE DRIP SET 16.6 CC/HR. MACHINE BEGAN BEEPING SHORTLY THEREAFTER WITH ZERO VOLUME SHOWING; INDICATING THE PT HAD REC'D A BOLUS OF THE ABOVE DRIP. A RATE OF 999 WAS INDICATED ON PUMP. NO INJURY TO THE PT WHO REMAINED STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INFUSION PUMP FRN ABBOTT LABORATORIES XL3M *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other