BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24617960 · Received March 17, 2026

    Report

    Report Number
    2016493-2026-14501
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 24, 2026
    Report Date
    February 27, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THERE WERE NO ISSUES IN FORMULARY. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE SERVER TO REVIEW THE AFFECTED MEDICATION IDENTIFICATION NUMBER (MED ID). THE TSS REVIEW THE ERROR BY USING KNOWLEDGE ARTICLE, UNABLE TO REMOVE MED: "ONE OR MORE ITEMS ARE NOT IN THE FORMULARY. CANNOT REMOVE" AND REVIEW OF THE FACILITY FORMULARY CONFIRMED THAT THE MEDID EXISTED ON THE SERVER. THE CUSTOMER REPORTED THAT MEDICATION 2100743 DUO NEBS APPEARED TO BE LOADED TWICE ON THE ES_ND MACHINE AND THAT ONE INSTANCE HAD BEEN UNLOADED, BUT ES_ND_MAIN DRAWER 1-INTERNAL COULD NOT BE FOUND. TSS VERIFIED ON THE SERVER THAT THE MEDICATION WAS ONLY LOADED TO ES_ND_TWR1 DRAWER 5, POCKET 16 AND NOT TO ES_ND_MAIN AS STATED. THIS WAS FURTHER CONFIRMED BY DIALING INTO THE STATION, REVIEWING STORAGE SPACE CONFIGURATION, AND RUNNING AN INVENTORY REPORT. 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 USER STATED THAT ALL NURSES WERE UNABLE TO REMOVE CERTAIN MEDICATIONS WITHOUT PERFORMING AN OVERRIDE AT THE STATIONS. THE CUSTOMER INDICATED THAT EACH TIME A NURSE ATTEMPTED TO PULL A MEDICATION, A MESSAGE APPEARED STATING, 1 OR MORE ITEMS NOT ON FORMULARY, CANNOT REMOVE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681767 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown