BEUDAMED
    FDA Adverse Event Summary report: N

    MEDSTATION

    MDR report key: 27465 · Received October 26, 1995

    Report

    Report Number
    MW1007445
    Date Received
    October 26, 1995
    Date of Event
    September 20, 1995
    Report Date
    October 23, 1995
    Manufacturer
    PYXIS CORPORATION
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PYRIX CORP. 9380 CARROLL PARK DR, SAN DIEGO, CA 92121. THE INSTRUCTIONS CLEARLY STATE THAT OVERFILLING OF THE PYXIS STORAGE COMPARTMENTS CAN LEAD TO JAMMING OF THE UNIT AND IN SOME EXTREME CASES DROPPING OF A PORTION OF THE CONTENTS INTO THE BOTTOM INTERNAL COMPARTMENT OF THE UNIT. IT SHOULD BE NOTED THAT EVEN IF THIS OCCURS, THE MEDICATION IN QUESTION IS STILL NOT SUBJECT TO EXTERNAL UNAUTHORIZED ACCESS. THUS, BASED ON MDR REPORTING REQUIREMENTS, THIS EVENT IS NOT OFFICIALLY REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSTATION POINT-OF-USE MEDICATION STATION PYXIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 *