BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24775959 · Received April 3, 2026

    Report

    Report Number
    2016493-2026-18977
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 12, 2026
    Report Date
    March 27, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 THE PYXIS REFILL MEDICATION WAS NOT CROSSING. A TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED THE PLX DATABASE AND CONFIRMED NO RECORDS IN THE INCOMING REQUEST, HISTORY, OR REJECTED TABLES, INDICATING REFILLS WERE NEITHER RECEIVED NOR REJECTED. THE INTERFACE SERVICES UTILITY WAS DEPLOYED WITH NO IMPROVEMENT. HIGH MEMORY UTILIZATION WAS IDENTIFIED ON THE CAREFUSION COORDINATION ENGINE (CCE) SERVER, AND THE SQL MEMORY CAP WAS REDUCED FROM 18 GB TO 12 GB. TRACE LOGS SHOWED INTERMITTENT KEY NOT FOUND EXCEPTION ERRORS, WHICH DID NOT IMPACT LOGISTICS MESSAGING. FURTHER REVIEW IDENTIFIED MISSING JIT REFILL ORDERS FOR STATION 5F2, WITH SEVERAL MED IDENTIFIER (MEDID) ABSENT FROM THE CCE JIT REFILL ORDER DATABASE AND NO HISTORICAL LOGS. THESE MEDIDS WERE CONFIRMED AS PENDED IN MED ES. TSS RESENT THE PENDS FOR STATION 5F2 AND VERIFIED UPDATES IN THE CCE DATABASE. STATION 5F2, WITH SEVERAL MEDIDS ABSENT FROM THE CCE JIT REFILL ORDER DATABASE AND NO HISTORICAL LOGS. THESE MEDIDS WERE CONFIRMED AS PENDED IN MED ES. TSS RESENT THE PENDS FOR STATION 5F2 AND VERIFIED UPDATES IN STATION 5F2, WITH SEVERAL MEDIDS ABSENT FROM THE CCE JIT REFILL ORDER DATABASE AND NO HISTORICAL LOGS. THESE MEDIDS WERE CONFIRMED AS PENDED IN MED ES. TSS RESENT THE PENDS STATION 5F2, WITH SEVERAL MEDIDS ABSENT FROM THE CCE JIT REFILL ORDER DATABASE AND NO HISTORICAL LOGS. TSS RESENT ALL PENDS FROM MED ES TO CCE FOR ALL NON CIISAFE ES DEVICES TO ENSURE ALIGNMENT. PHARMACY WAS NOTIFIED, AND ALL PENDS WERE SUCCESSFULLY RESENT. THE SYSTEM FUNCTIONED AS INTENDED AFTER TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER USER STATED THAT REFILL MEDICATIONS WERE NOT CROSSING OVER. THE CUSTOMER NOTED THAT THE MEDICATION QUANTITY EXCEEDED THE MAXIMUM CAPACITY AND REQUESTED VERIFICATION OF THE JIT SERVER CONNECTION TO THE PYXIS MACHINE. THE STATION WAS REBOOTED AND THE MEDICATION WAS CHECKED; HOWEVER, THE ISSUE PERSISTS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE 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
    837688 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: IT.