BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 21701760 · Received March 26, 2025

    Report

    Report Number
    2016493-2025-68963
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STATION'S DATABASE HAD BLOATED, EXCEEDING 10 GB. A TECHNICAL SUPPORT SPECIALIST RAN A QUERY TO SHRINK THE DATABASE, REPAIRED THE MED APPLICATION, AND REBOOTED THE STATION IN APPLICATION MODE TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, NURSE WAS UNABLE TO REMOVE THE MEDICATIONS, WHICH LED TO A RETURN TO THE MAIN PAGE. THIS INCIDENT RESULTED IN A DELAY TO PATIENT CARE, SINCE NURSE HAD TO PHYSICALLY GO TO THE PHARMACY TO OBTAIN THE REQUIRED MEDICATIONS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786006 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown