BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER PCA II

    MDR report key: 379791 · Received March 5, 2002

    Report

    Report Number
    379791
    Event Type
    Death
    Date Received
    March 5, 2002
    Date of Event
    January 18, 2002
    Report Date
    March 5, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    MEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY IN 2002. PT PLACED ON PT CONTROLLED ANALGESIC PUMP INFUSING DEMEROL FOR PAIN MANAGEMENT. PT COMPLAINED OF NAUSEA AND MEDICATED WITH PHENERGAN AT 6:15 PM AND 8:15 PM. PT CONTINUED TO COMPLAIN OF NAUSEA AND MEDICATED WITH COMPAZINE AT 11:15 PM. AT 1:00 AM, PT FOUND UNRESPONSIVE AND CODE CALLED. ADVANCE CARDIAC LIFE SUPPORT WAS INITIATED BUT RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. PT PRONOUNCED DEAD AT 0200 HOURS THE NEXT DAY. CORONER NOTIFIED OF UNEXPECTED DEATH. AUTOPSY REPORT COMPLETED AND RULED CAUSE OF DEATH A MEPERIDINE OVERDOSE. THIS MATTER IS CURRENTLY UNDER INVESTIGATION. IT SHOULD BE NOTED THAT IT IS NOT KNOWN WHICH PCA PUMP WAS USED AT THE TIME, BUT DUE TO THE CORONER'S REPORT, ALL PCA PUMPS ARE BEING EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER PCA II PATIENT CONTROLLED ANALGESIC PUMP MEA BAXTER HEALTHCARE CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death