BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22748178 · Received August 8, 2025

    Report

    Report Number
    2016493-2025-103537
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 1, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    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, 21-OCT-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 ALL USERS WERE UNABLE TO LOGIN TO ALL 3 STATIONS. A TECHNICAL SUPPORT SPECIALIST VERIFIED LOGIN WORKS, DOMAIN FORMAT IS CORRECT, AND AD (ACTIVE DIRECTORY) GROUP "PYXIS" IS VALID. IDS LOGS SHOWED INVALID CREDENTIALS. PASSWORD RESET DIDN¿T RESOLVE ISSUE. LOGS INDICATED GROUP MISMATCH. GROUP FOUND IN AD, BUT USER STILL NOT AUTHENTICATED. PASSWORD RESET DIDN¿T RESOLVE ISSUE. THE TSS LOGGED INTO PES AND REVIEWED USER DOMAINS. FOR DOMAIN CCHD1, THE CONTROLLER WAS OUTDATED (FCH-DC-00). DISABLED THE ACTIVE OPTION AND SAVED THE CHANGES. RE-ENABLED THE ACTIVE OPTION AND SAVED AGAIN, WHICH UPDATED THE CONTROLLER ID TO CCHD-DC02. FINALLY, RESTARTED THE AD SYNCHRONIZATION SERVICE TO APPLY THE CHANGES. THE TSS CONFIRMED THAT THERE WAS NO REPORTED REOCCURRENCE OF 'UNABLE TO AUTHENTICATE' ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ MEDSTATION¿ ES SYSTEM ALL USERS WERE UNABLE TO LOGIN TO ALL 3 STATIONS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999328 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown