BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23800473 · Received December 15, 2025

    Report

    Report Number
    2016493-2025-143366
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 16, 2025
    Report Date
    December 3, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403425820
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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, 22-FEB-2018 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 WAS NOT BEING PURGED, AND ALL THE STATIONS HAVE A DATABASE SIZE OF ALMOST 10 GB. A TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THAT THE PURGE DELETION PROCESS WAS STOPPED BECAUSE THE E: DRIVE WAS FULL, WHICH PREVENTED THE SYSTEM FROM COMPLETING THE PURGE OPERATION. THIS LED TO THE ACCUMULATION OF DATA AND SUBSEQUENT DELAYS. THEN THE TSS CONFIRMED THAT THE DEVICE SERIAL NUMBERS WITH THE CUSTOMER. THEN VALIDATE IF THE E: DRIVE SPACE ISSUE HAD BEEN RESOLVED AND PURGE PROCESSES RESUMED. THEN ENSURE THE PROPER LOG BACKUP AND DISK SPACE MONITORING TO PREVENT RECURRENCE, MONITORED THE PURGE ABOUT 3 WEEKS AND ITS REACH THE CURRENT DATE/TIME FOR THE 9 STATIONS, THEN FOLLOWED THE KNOWLEDGE ARTICLE. 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¿ ES SERVER, ALL STATIONS HAD NOT BEEN PURGED. 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
    790252 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501 10885403425820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERIC BD PYXIS¿ MEDSTATION¿ ES