BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24398570 · Received February 20, 2026

    Report

    Report Number
    2016493-2026-07934
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 5, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SERVER SYSTEM HAD ANA ISSUE WHERE REPLENISHMENT MESSAGES WERE NOT CROSSING. A TECHNICAL SUPPORT SPECIALIST (TSS) FOUND ISSUES IN THE DEVICE, DATABASE TOOL, AND JIT. THE TSS IDENTIFIED THAT THE TRIGGERS FOR DEVICE JIT BATCH 2, BYC - JIT BATCH 3, AND BYC - JIT BATCH 6 ALL HAD A PICK AREA FILTER EXCLUSION FOR NON-AUTOMATION. THE TSS CHECKED THE DEVICE FACILITY FORMULARY FOR MEDICATION ID: MORP03L AND FOUND THAT THE REPLENISHMENT PICK AREA WAS SET TO NON-AUTOMATION. IN ORDER FOR MEDICATION ID: MORP03L TO TRIGGER REFILLS, THE REPLENISHMENT PICK AREA NEEDED TO BE UPDATED IN THE DEVICE. THE TSS SHARED THESE FINDINGS WITH THE CUSTOMER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TESTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER MORPHINE (NEONATAL) 0.3 MG (0.75 ML) SOLUTION (MEDID MORP03L) WAS NOT CROSSING FOR STOCK-OUTS OR PYXIS REPLENISHMENTS IN BATCH PROCESSING. THEY TRIED UNLOADED AND RELOADED THE PRODUCT, BUT REPLENISHMENT MESSAGES STILL DID NOT GENERATE, CAUSING DELAYS IN PATIENT CARE. 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
    461909 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: CNICU| SN: (B)(6), LOCATION: PHARMACY