BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 225222 · Received May 21, 1999

    Report

    Report Number
    2921482-1999-00084
    Event Type
    Other
    Date Received
    May 21, 1999
    Date of Event
    March 1, 1999
    Report Date
    April 21, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE DILAUDID IN A 0.2MG/ML CONCENTRATION WITH A 0.1MG PCA DOSE. COMPLETE DEVICE SETTINGS WERE NOT AVAILABLE. IT WAS REPORTED THAT THE PT RECEIVED A 1 MG PCA DOSE. IT WAS NOT KNOWN IF THIS WAS DUE TO A PUMP PROGRAMMING ERROR OR TO A PHARMACY MIXTURE ERROR. THE PT BECAME "OBTUNDED" AND REQUIRED CLOSE OBSERVATION IN THE POST ANESTHESIA CARE UNIT FOR OVER AN HOUR LONGER THAN USUAL. THE PT DID NOT REQUIRE MEDICAL INTERVENTION. THE EFFECTS OF THE DILAUDID WERE ALLOWED TO WEAR OFF OVER TIME AND THE PT WAS THEN TRANSFERRED TO A REGULAR NURSING UNIT. THE PT DID NOT EXPERIENCE ANY ADVERSE SEQUELAE. THE PUMP MEDICATION VIAL WAS SWITCHED OUT AND THE PAIN THERAPY RESTARTED AFTER THE PT SYMPTOMS WORE OFF. NO ADDITIONAL INFO WAS AVAILABLE.

    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 37 YR Other