BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 490907 · Received October 21, 2003

    Report

    Report Number
    490907
    Event Type
    Malfunction
    Date Received
    October 21, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 9, 2003
    Manufacturer
    ABBOTT LABORATORIES
    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

    PUMP ALARMED "AIR IN LINE". RN PURGED X3 WITHOUT SUCCESS. VTB 8.8MG. ACTUAL VOLUME (MG) 17MG. CONTAINER SIZE SET AT 30MG. VOLUME INFUSED 18.9. 18.9 + 8.8 DOES NOT EQUAL 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT APM II FRN ABBOTT LABORATORIES APM II *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other