BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULATORY PCA PUMP

    MDR report key: 25403 · Received September 11, 1995

    Report

    Report Number
    MW1006887
    Event Type
    Malfunction
    Date Received
    September 11, 1995
    Date of Event
    August 24, 1995
    Report Date
    August 31, 1995
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    PT WAS ABLE TO BREAK INTO THE PUMP, & REMOVE THE PCA BAG WITH APPROX 90CC OF IMG/IML MORPHINE SULFATE. THE PT MANAGED TO PRY OPEN THE PUMP AT THE INDENTATION NEAR THE LOCK. THIS WAS DUPLICATED IN THE PHARMACY WITH A REGULAR PAIR OF SCISSORS. THE LOCK PROVIDES A FALSE SENSE OF SECURITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR