BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 25183404 · Received May 15, 2026

    Report

    Report Number
    2016493-2026-29574
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 25, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF CODES AND MANUFACTURER NARRATIVE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM HAD AN ISSUE WHERE PYXIS STOCK OUT DID NOT POPULATE IN LOGISTICS. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED BACK INTO THE CAREFUSION COORDINATION ENGINE (CCE) AND REVIEWED THE RPL MESSAGE, IDENTIFYING THAT THE INTERIMFILLTYPE WAS SET TO ¿C¿ (CRITICAL LOW), WHICH GENERATES A CRITICAL LOW MESSAGE EVEN WHEN THE END COUNT AND TOTAL STATION QUANTITY REACH ZERO. FOR MEDICATION ID, IT WAS OBSERVED THAT ON STATION FVPK2HEART THE MEDICATION HAD MAX 1, MIN 0, AND CURRENT 0 AFTER OUTDATING, AND ON STATION FV3LD THE MEDICATION HAD MAX 2, MIN 1, AND CURRENT 0, YET BOTH TRIGGERED A CRITICAL LOW INSTEAD OF A STOCKOUT. THE ISSUE WAS ISOLATED TO THE OUTDATE TRANSACTION, WHERE IT INCORRECTLY TRIGGERED A CRITICAL LOW INSTEAD OF A STOCKOUT MESSAGE. UPON REVIEWING THE INTERFACE SETTINGS WHERE TRANSACTIONS ARE MONITORED AND STOCKOUT MESSAGES ARE TRIGGERED WHEN QUANTITY REACHES ZERO, THE TSS REMOVED THE EXPIRED ITEM TRANSACTION AND RE ADDED IT TO THE CONFIGURATION TO ENSURE PROPER STOCKOUT MESSAGE GENERATION, RESOLVING THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, CATALOG, MODEL, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE 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 THAT WHEN USING THE BD PYXIS¿ ES SERVER STOCK OUT FOR INSULIN WAS NOT POPULATED IN LOGISTICS FOR TWO DEVICES DESPITE THE MEDICATION BEING OUTDATED. THE CUSTOMER REPORTED 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 STOCK OUT FOR INSULIN WAS NOT POPULATED IN LOGISTICS FOR TWO DEVICES DESPITE THE MEDICATION BEING OUTDATED. THE CUSTOMER REPORTED 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
    334043 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1