BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 25065995 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25526
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 5, 2026
    Report Date
    April 9, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403518348
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY: (B)(6). 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, 30-SEP-2022 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 REPORTS WERE NOT PRINTING. A TECHNICAL SUPPORT SPECIALIST INVESTIGATION REVEALED THAT THE HOSPITAL IT HAD CHANGED THE SERVICE ACCOUNT PASSWORD DURING THE INCIDENT. HOSPITAL INFORMATION TECHNOLOGY (HIT) PROVIDED A NEW CFNSERVICE PASSWORD. UPDATED THE NEW PASSWORD ON THE APP, RTP, DB, AND TEST SERVERS PER KA (MED ES CHANGING PASSWORD FOR CFNSERVICE AND CFNADMIN ACCOUNTS). THE TSS REBOOTED THE SYSTEM AND RESET THE TOP 1 RETRY ATTEMPT QUANTITY TO '0'. THE STOCKOUT REPORT PRINTED SUCCESSFULLY. THE TSS VERIFIED THAT EVERYTHING WAS WORKING AS EXPECTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, AUTOMATED REPORTS HAD NOT BEEN WORKING FOR SOME TIME, AS THE CUSTOMER HAD NOT RECEIVED THOSE REPORTS. CONNECTIVITY FROM THE MACHINES BACK TO THE SERVER WAS NOT COMMUNICATING PROPERLY TO PRINT THE AUTOMATIC REPLENISHMENT REPORTS. THIS ISSUE HAD CAUSED PATIENT SAFETY CONCERNS, AS MEDICATION DOSES AND DELIVERIES WERE DELAYED. 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
    317860 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501 10885403518348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown