BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23246454 · Received October 8, 2025

    Report

    Report Number
    2016493-2025-120458
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 15, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 21-APR-2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DS CLIENT OLTP DATA BASE WAS IN SUSPECT RECOVERY PENDING STATE. A TECHNICAL SUPPORT SPECIALIST HAD DIALED IN AND PERFORMED A STRUCTURED RECOVERY USING KNOWLEDGE ARTICLES MED APPLICATION NOT LAUNCHING AUTOMATICALLY STATION AT BLUE SCREEN, KA RECOVER REPAIR A CORRUPTED DS CLIENT OLTP DATABASE, KA DROP AND RECREATE DS CLIENT OLTP WHEN NORMAL REPAIR COULD NOT PROCEED, AND KA PROPER DATASYNC PROCEDURE & HOW TO PLACE NEW DB IN ES STATION. THE SPECIALIST STOPPED THE DATA SYNC AND MAINTENANCE SERVICES, STOPPED THE SQL SERVER SERVICE, MOVED OR REMOVED THE DS CLIENT OLTP FILES, RESTARTED SQL SERVER, DROPPED THE DS CLIENT OLTP DATABASE, AND PERFORMED A FULL SYNC PER KA PROPER DATASYNC PROCEDURE & HOW TO PLACE NEW DB IN ES STATION. THE MED APPLICATION WAS REPAIRED, THE DS CLIENT OLTP RECOVERY MODEL WAS CHANGED FROM FULL TO SIMPLE, THE DATA SYNC AND MAINTENANCE SERVICES WERE RESTARTED, AND THE NETWORK INTERFACE WAS SET TO 100 MB HALF DUPLEX TO STABILIZE COMMUNICATION. THE CUSTOMER VERIFIED THE STATION WAS CLEARED IN THE HEALTH SIGHT VIEWER (HSV), THE SYSTEM WAS MONITORED FOR 24 HOURS WITHOUT RECURRENCE, AND THE CASE WAS CLOSED. 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 HAD LOGIN ISSUE AND DATABASE WAS NOT FOUND. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662965 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown