BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PAIN MGR II

    MDR report key: 478364 · Received August 15, 2003

    Report

    Report Number
    478364
    Event Type
    Malfunction
    Date Received
    August 15, 2003
    Date of Event
    July 30, 2003
    Report Date
    August 13, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PCA PUMP USED BY PT. NEW VIAL INSERTED AT 0250. PT REPORTED "PUMP NOT WORKING AS BEFORE". NURSE CHECKED HISTORY AND REVIEWED FUNCTIONS. PUMP READ 30.0 MG VTBI WITH 0.0 MG INFUSED. VIAL CONTAINED APPROX 18ML (MG) BY VISUALIZATION. NURSE LEFT THE ROOM TO GET ANOTHER PUMP. WHEN SHE CHANGED PUMP VTBI READ 26 MG AND VOLUME INFUSED 4MG. AT THAT TIME 14(MG) CONTAINED IN VIAL. PUMP REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PAIN MGR II PCA MEA ABBOTT LABORATORIES APM II *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other ABBOTT PAIN MGR II.