BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA MACHINE

    MDR report key: 613126 · Received June 3, 2005

    Report

    Report Number
    613126
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Date of Event
    May 20, 2005
    Report Date
    June 3, 2005
    Manufacturer
    BAXTER HEALTH CARE CORPORATION
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PCA MACHINE DID NOT DELIVER THE CORRECT AMOUNT OF MORPHINE AS PROGRAMMED. ORDER FOR PCA MORPHINE READ AS FOLLOWS: PCA: 1.5MG PER INJECTION, DELAY:6 MIN BETWEEN INJECTIONS, MAXIMUM HOURLY DOSE:10, BOLUS:0. DURING A 3 HOUR PERIOD THE PATIENT RECEIVED 0.9MG OF MORPHINE WITH 6 ATTEMPTS AND 6 INJECTIONS. THERE WERE NO ALARMS ACTIVATED ON THE MACHINE. THE PATIENT WAS SEEN AND EXAMINED BY THE DOCTOR. THERE WERE NO ADVERSE INJURIES TO PATIENT.A TEST PERFORMED BY BIO-ENGINEERING DEPARTMENT. THE BATTERY IN PUMP WAS CHANGED. THE PCA PUMP WAS PROGRAMMED AND APPEARED TO BE FUNCTIONING PROPERLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MACHINE PAIN MANAGEMENT SYSTEM MEA BAXTER HEALTH CARE CORPORATION N/A NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR