BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25013214 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24277
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 3, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 11-OCT-2019 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 SYSTEM STOCK OUT REPORT WAS NOT PRINTING. A TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED THE MEDICATION INVENTORY, SPECIFICALLY MEDICATION ID 559B, AND FOUND THAT THE CURRENT QUANTITY WAS EIGHT. THIS MAY HAVE BEEN THE REASON THE STOCKOUT DID NOT PRINT. ALTERNATIVELY, THE ISSUE MAY HAVE BEEN CAUSED BY A MISMATCH BETWEEN THE QUANTITY DISPLAYED ON THE STATION AND THE QUANTITY RECORDED ON THE SERVER. THE TSS CONFIRMED THE FINDINGS WITH THE CUSTOMER AND ADVISED RUNNING A DEVICE INVENTORY REPORT TO VERIFY THAT THE QUANTITIES MATCHED WHAT WAS PHYSICALLY LOCATED IN THE STATION. THE FINDINGS WERE SHARED WITH THE CUSTOMER AND CONFIRMED. THE ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, USER REPORTED NOT RECEIVING THE STOCK-OUT REPORT IN PYXIS FOR BUPRENORPHINE 0.5 MG TABLET 559B. THE REPORT DID NOT PRINT ON THE KPH PYXIS ED CABINET. 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
    572857 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown