BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24640118 · Received March 19, 2026

    Report

    Report Number
    2016493-2026-15187
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403489464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 14-OCT-2019 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 SYSTEM HAD AN ISSUE WHERE THE USER WAS UNABLE TO LOGIN TO LOGISTIC INVENTORY MANAGER. A TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED THE EVENT VIEWER AND IDENTIFIED TWO CRITICAL EVENTS RELATED TO KERNEL POWER. THE FIELD SERVICE ENGINEER (FSE) INFORMED THAT THE SERVER IN QUESTION IS A VIRTUAL MACHINE AND THEREFORE DID NOT INVOLVE ANY BATTERIES FOR REPLACEMENT. THE FSE ADVISED THAT THE CUSTOMERS INFORMATION TECHNOLOGY (IT) TEAM SHOULD BE ENGAGED FOR FURTHER TROUBLESHOOTING, AS THE VM IS ON THE CUSTOMERS NETWORK BUT MANAGED BY BD. THE TSS INFORMED THE CUSTOMER THAT THE ISSUE WAS CAUSED BY THE SYSMON64 PROCESS (SYSTEM ACTIVITY MONITOR) CONSUMING EXCESSIVE MEMORY ON THE SERVER. SYSMON WAS NOT INCLUDED WITH WINDOWS SERVER BY DEFAULT AND MUST BE INTENTIONALLY INSTALLED AND CONFIGURED, WHICH CLASSIFIES IT AS THIRD-PARTY SOFTWARE UNDER THE CURRENT VM DEPLOYMENT MODEL FOR THE FACILITY. TO RESOLVE THE ISSUE, THE CUSTOMERS IT TEAM WOULD NEED TO EITHER UNINSTALL SYSMON64.EXE FROM THE SERVER OR RECONFIGURE IT TO ADDRESS THE MEMORY LEAK. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Additional Manufacturer Narrative · 0

    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 THAT WHEN USING THE BD PYXIS¿ ES SERVER, UNABLE TO LOGIN TO LOGISTIC. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, UNABLE TO LOGIN TO LOGISTIC. 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
    545024 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501 10885403489464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown