BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 22468975 · Received July 10, 2025

    Report

    Report Number
    2016493-2025-95207
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 10, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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 TRACING DATABASE SIZE WAS 213 GB. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE CCE, TRUNCATED THE MESSAGE LOGS TABLE AND PROCEEDED TO SHRINK THE TRACING DATABASE AND CLEARED THE CONTENTS OF THE SEARCH INDEX FOLDER AND THEN RESTARTED THE CCE SERVICES TO ENSURE OPTIMAL PERFORMANCE. TSS SENT AN EMAIL TO THE CUSTOMER SUMMARIZING THE STEPS TAKEN AND RECOMMENDED REDUCING THE LOG RETENTION PERIOD TO 7 OR 14 DAYS TO PREVENT SIMILAR ISSUES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE. E4 INITIAL REPORTER OCCUPATION: INTERMEDIC SENIOR HCIS TECHNICAL SPECIALIST. D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, PATIENT DETAILS WERE NOT SHOWED ON THE STATIONS AND SERVER AND ERROR CODE 500 WAS DISPLAYED ON STATION. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678100 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown S/N: 15080137 DEVICE NAME: PYXIS CCCL OUT