BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 260331 · Received January 21, 2000

    Report

    Report Number
    2921482-2000-00014
    Event Type
    Injury
    Date Received
    January 21, 2000
    Date of Event
    December 20, 1999
    Report Date
    December 20, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADVERSE EVENT REPORTED WHILE THE DEVICE WAS IN USE. A PATIENT WAS CODED WHILE RECEIVING INTRAVENOUS PAIN MANAGEMENT THERAPY. THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED NARCOTIC IN THE PCA ONLY MODE OF DELIVERY AT 0.5MG/DOSE WITH AN UNSPECIFIED LOCKOUT PERIOD. THE USER FACILITY WOULD NOT REVEAL THE CODE OUTCOME OR CURRENT PATIENT STATUS. NARCAN WAS ADMINISTERED, BUT THE DOSAGE AND FREQUENCY OF ADMINISTRATION WAS UNSPECIFIED. THOUGH REQUESTED, THIS WAS ALL THE INFORMATION THAT THE USER FACILITY WOULD SHARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA PLUS INFUSER INFUSION PUMP MEA ABBOTT LABORATORIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention