BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23062534 · Received September 16, 2025

    Report

    Report Number
    2016493-2025-114315
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 14, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES & CONCOMITANT MED PROD DATA 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, 29-APR-2016 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 OVERRIDE DID NOT TURN ON AUTOMATICALLY ON DEVICES. A TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE AND IDENTIFIED THAT THE SYNCHRONIZATION SERVER REMAINED UP WHILE MAIN SERVER WAS DOWN, PREVENTING STATIONS FROM ENTERING CRITICAL OVERRIDE. TSS ALSO CHANGED THE LOGIN TO ALLOW THE SYSTEM TO MEASURE IF THE ACTIVE DIRECTORY WAS STOPPED FOR AN EXTENDED PERIOD OF TIME AND AUTOMATICALLY SETS DEVICES TO CRITICAL OVERRIDE. TSS ALSO ADVISED TO GO TO THE LATEST VERSION OF ES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE. D.10 CONCOMITANT MED PROD DATA - SN-(B)(6) LN- SLMC-MEDSURG1, SN-(B)(6) LN-SLMC-ED, SN-(B)(6) LN-SLMC-ICUSLR, SN-(B)(6) LN-SMLC-MEDSURG2, SN-(B)(6) LN-SLMC-WCC (B)(6) LN-SLMC-LD1, SN-(B)(6) LN-SLMC-MBU, SN-(B)(6) LN-SLROR, SN-(B)(6) LN-SLMC-PAC, SN-(B)(6) LN-SLRPCUU, SN-(B)(6) LN-SLMC-SL-AN03, SN-(B)(6) LN-SLMC-SL-AN04, SN-(B)(6) LN-4NE1, SN-(B)(6) LN-5SE, SN-(B)(6) LN-4SE1, SN-(B)(6) LN-4SE2, SN -(B)(6) LN-5NE, SN-(B)(6) LN-5SW, SN-(B)(6) LN-CCU, SN-(B)(6) LN-ED, SN-(B)(6) LN-ICU, SN-(B)(6) LN-OR-1, SN-(B)(6) , LN-2SE1, SN-(B)(6) LN-C-SECT, SN-(B)(6) LN-3NE1, SN-(B)(6) LN-3SE2, SN-(B)(6) LN-4NE3, SN-(B)(6) LN-4NW,SN-(B)(6) LN-CATHLAB, SN-(B)(6) LN-CATHLAB1, SN-(B)(6) LN-2SE2, SN-(B)(6) LN-OCHCT, SN-(B)(6) LN-DIALYSIS, SN-(B)(6) LN-ED2, SN-(B)(6) LN-INFCENTER, SN-(B)(6) LN-OCHIRHOLD, SN-(B)(6) LN-LD, SN-(B)(6) LN-LDRECOVERY SN-(B)(6) LN-NICU-A, SN-(B)(6) LN-NUCMED, SN-(B)(6) LN-OR-2, SN-(B)(6) LN-ORHOLDING, SN-(B)(6) LN-PACU1, SN-(B)(6) LN-OMCFAMPRAC, SN-(B)(6) LN-OMCURO, SN-(B)(6) LN-5NW, SN-(B)(6) LN-IR, SN-(B)(6) LN-XXED3, SN-(B)(6) LN-OMCSPECIALTY, SN-(B)(6) LN-OMCWCSURSP, SN-(B)(6) LN-OCHED4, SN-(B)(6) LN-ANES-OR2, SN-(B)(6) LN-ANES-OR3, SN-(B)(6) LN-OCHANSCATH, SN-(B)(6) LN-ANES-CS2, SN-(B)(6) LN-ANES-CS3, SN-(B)(6) LN-ANES-OR1, SN-(B)(6) LN-ANES-OR10, SN-(B)(6) LN-ANES-OR11, SN-(B)(6) LN-ANES-OR4, SN-(B)(6) LN-ANES-OR5, SN-(B)(6) LN-ANES-OR6, SN-(B)(6) , LN-ANES-OR7, SN-(B)(6) LN-ANES-OR8, SN-(B)(6) LN-ANES-OR9

    Additional Manufacturer Narrative · 0

    D4: UNIQUE DEVICE IDENTIFIER NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE OVERRIDE FUNCTION FAILED TO ACTIVATE AUTOMATICALLY ON THE DEVICES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE OVERRIDE FUNCTION FAILED TO ACTIVATE AUTOMATICALLY ON THE DEVICES. 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
    2561053 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown