BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24699209 · Received March 26, 2026

    Report

    Report Number
    2016493-2026-16803
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THERE WERE PERFORMANCE ISSUES ON THE PYXIS DATABASE SERVER. THE TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THAT CCE MESSAGING FUNCTIONED NORMALLY AND THAT MESSAGES FROM CERNER AND EPIC WERE RECEIVED AND FORWARDED WITHOUT DELAY. HOWEVER, MESSAGING AND DATABASE REVIEWS SHOWED THAT MESSAGES DID NOT COMPLETE PROCESSING ON THE SERVER. A KNOWLEDGE ARTICLE FIX FOR INBOUND MESSAGES STUCK ON AVAILABLEFORPROCESSING=1 HAD BEEN PARTIALLY IMPLEMENTED EARLIER, MISSING A REQUIRED SERVICE BEHAVIOR TAG. THE TSS ADDED THE MISSING TAG AND RESTARTED EXTERNAL MESSAGING. THE DATABASE SERVER EXPERIENCED A SUDDEN CPU SHORTAGE WHILE MEMORY REMAINED SUFFICIENT. THE TSS REDUCED SQL DEDICATED MEMORY FROM 51 GB TO 48 GB TO PREVENT RESOURCE CONTENTION. THE ISSUE ESCALATED TO A MIB WHEN CPU USAGE REACHED 99%, WITH SQL IDENTIFIED. THE HOSPITAL DBA TEAM IDENTIFIED EXCESSIVE DATABASE ACCESS BY THE MAINTENANCE SERVICE, WHICH CAUSED LOCKS AND DELAYS. THE HOSPITAL IT TEAM STOPPED THE MAINTENANCE SERVICE, CORRECTED CPU ALLOCATION ISSUES, AND SUCCESSFULLY DRAINED ALL MESSAGE QUEUES. MAINTENANCE WAS LATER RESTARTED AND MONITORED, AND THE DATABASE REMAINED STABLE WITH NORMAL CPU USAGE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST AND HOSPITAL IT TEAM TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, DEVICES WERE NOT CROSSING OVER NEW MEDICATION ORDERS FROM THE SERVER AND WERE NOT CONVERTING THE ORDERS TO OVERRIDE STATUS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, DEVICES WERE NOT CROSSING OVER NEW MEDICATION ORDERS FROM THE SERVER AND WERE NOT CONVERTING THE ORDERS TO OVERRIDE STATUS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757815 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: NWEDMAIN.| SN: (B)(6), LOCATION: NWEDMAIN.