BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA II PUMP

    MDR report key: 405793 · Received July 12, 2002

    Report

    Report Number
    6000001-2002-01295
    Event Type
    Death
    Date Received
    July 12, 2002
    Date of Event
    June 24, 2001
    Report Date
    June 20, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A SUMMONS FROM THE LEGAL DEPT REPORTS: A PT WAS ADMITTED TO THE HOSPITAL ER TO TREAT A RUPTURED ACHILLES TENDON. APPROX 6PM IN 2001, THE PT WAS TRANSFERRED TO A PT ROOM IN THE HOSPITAL WITH SURGERY SCHEDULED FOR THE FOLLOWING MORNING. THE PT WAS CONNECTED TO A PCA PUMP TO DELIVER DOSES OF MORPHINE WAS ADMINISTERED VIA THE PUMP TWO WAYS, (1) BY NURSES MANUALLY ACTIVATING THE PUMP, (2) BY THE PT. THE PUMP WAS PROGRAMMED TO LIMIT ONLY 8MG OF MORPHINE TO BE SELF ADMINISTERED EVERY HOUR. SOMETIME AFTER 2:00AM THE NEXT DAY THE PT WAS FOUND BY A NURSE IN "MORTAL DANGER", SPECIFICALLY, PT WAS NOT BREATHING, WAS UNCONSCIOUS AND COULD NOT BE AROUSED AND HAD PINPOINT PUPILS. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP PCA PUMP MEA BAXTER HEALTHCARE CORP. PCA II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death