BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25169693 · Received May 14, 2026

    Report

    Report Number
    2016493-2026-28901
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 17, 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
    WA, US
    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, 20-MAY-2024 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 DEVICE INVOLVED IN THE INCIDENT, THE TECHNICAL SUPPORT SPECIALIST (TSS) IDENTIFIED A SERVER ISSUE WHERE ALL DATABASES WERE IN A RECOVERY PENDING STATE AFTER A REBOOT. SQL LOGS SHOWED SEVERE I/O AND ENCRYPTION KEY ERRORS (ERROR 824), INDICATING POTENTIAL DATABASE CORRUPTION. FURTHER REVIEW REVEALED MISSING OLTP DATA FILES AND SQL/EVENT VIEWER ERRORS RELATED TO MISSING OR CORRUPTED SQL LOG AND REPORT FILES, WHICH PREVENTED DATABASE RECOVERY.THE TSS REVIEWED RECENT WINDOWS UPDATES AND IDENTIFIED KB5084821, WHICH HAD INSTALLED SQL SERVER 2016/2012 BROWSER, SQL SERVER, AND VSS WRITER COMPONENTS ON APRIL 15. AFTER UNINSTALLING THESE COMPONENTS AND REBOOTING THE SERVER, ALL DATABASES CAME BACK ONLINE SUCCESSFULLY.IN CONSULTATION WITH A PRODUCT SUPPORT ENGINEER (PSE), THE TSS INFORMED THE CUSTOMER THAT THE INSTALLED KNOWLEDGE BASE (KB) WAS EXTERNAL AND NOT BD-APPROVED. IT WAS EXPLAINED THAT UNAPPROVED KBS COULD NOT BE VERIFIED OR SUPPORTED BY BD AND MIGHT CAUSE THE ISSUE TO RECUR. THE CUSTOMER WAS ADVISED TO AVOID INSTALLING OR UPDATING ANY KBS THAT WERE NOT OFFICIALLY APPROVED AND RELEASED BY BD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DEVICE WAS IN DISCONNECTED MODE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454654 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown