BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23753386 · Received December 9, 2025

    Report

    Report Number
    2016493-2025-141608
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 21, 2025
    Report Date
    November 27, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 COMPLAINTS 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, 09-AUG-2017 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 USERS WERE UNABLE TO LOG IN. THE TECHNICAL SUPPORT SPECIALIST (TSS) DETERMINED DEVICE HAD A DATABASE LOG FILE OCCUPYING 72 GB, LEAVING ONLY 200 MB OF FREE SPACE ON THE D DRIVE. THE DSCLIENTOLTP DATABASE WAS CHECKED IN SQL SERVER MANAGEMENT STUDIO, AND ITS RECOVERY MODE WAS SET TO FULL. THE RECOVERY MODE WAS CHANGED TO SIMPLE, AND THE DATABASE WAS SHRUNK, REDUCING THE LOG FILE TO APPROXIMATELY 500 MB. THIS FREED UP 74 GB OF SPACE ON THE D DRIVE. AFTER THESE ACTIONS, THE CUSTOMER TESTED LOGIN SUCCESSFULLY, AND THE CONFIRMED THE ISSUE WAS RESOLVED. 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 DEVICE ON CRITICAL OVERRIDE AND USERS UNABLE TO LOG IN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
    2813706 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown