BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22357862 · Received June 30, 2025

    Report

    Report Number
    2016493-2025-91435
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 27, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    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, 23-NOV-2021 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 STATION DISPLAYED AN ORDER AS DUE EARLIER THAN ITS ACTUAL SCHEDULED DATE. A TECHNICAL SUPPORT SPECIALIST (TSS) PROVIDED FEEDBACK TO THE CUSTOMER REGARDING A BUG IN THE QUICK AND HOLD (QNH) STANDARD FREQUENCY CODE IN ES 1.6.1 AND EARLIER VERSIONS. THE TSS GUIDED THE CUSTOMER TO UPDATE FREQUENCY CODES USING QNH GREATER THAN 24 HOURS OR TO USE QUICK AND DONE (QND) INSTEAD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES AUXILIARY STATION DISPLAYED AN ORDER AS DUE EARLIER THAN ITS ACTUAL DATE. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927128 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown