BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25239515 · Received May 21, 2026

    Report

    Report Number
    2016493-2026-30783
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 5, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, 11-NOV-2025 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 STATION REQUIRED REIMAGE FROM THE HOST CONVERSION. A TECHNICAL SUPPORT SPECIALIST (TSS) REMOTELY ACCESSED THE STATION, DELETED THE DSCLIENTOLTP DATABASE, AND ATTEMPTED TO REPAIR THE MED APPLICATION, WHICH INITIALLY RESULTED IN A FATAL ERROR. THE TSS LAUNCHED STRUCTURED QUERY LANGUAGE SQL SERVER MANAGEMENT STUDIO (SSMS) AS AN ADMINISTRATOR AND GRANTED THE SYSTEM ADMIN ROLES TO THE SYSTEM AND CAREFUSION ADMIN USERS. THE MED APPLICATION REPAIR WAS THEN COMPLETED SUCCESSFULLY, FOLLOWED BY A FULL SYNCHRONIZATION. MAINTENANCE SERVICES WERE RESTARTED, AND HOST CONVERSION WAS CONFIRMED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, STATION PX-H-5SA1 HAD BEEN REIMAGED FROM HOST CONVERSION. 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
    409396 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1