BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22496252 · Received July 14, 2025

    Report

    Report Number
    2016493-2025-96441
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    September 16, 2023
    Report Date
    July 8, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING JANUARY 2022-DECEMBER 5, 2024, UNDER CAPA 10308384. THE LATE SUBMISSION OF THIS REPORT IS JUSTIFIED BY THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 27-AUG-2020 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 DEVICE DRAWER FAILED AND NOT DETECTED ON THE BINARY UNIFIED SYSTEM. THE FIELD SERVICE ENGINEER HAD RESEATED PYXIBUS, RETRACTOR BAND, ROW RIBBON CABLE TO DRAWER CONTROLLER AND REBOOTED STATION TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOT BY THE FIELD SERVICE ENGINEER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD PYXIS¿ MEDSTATION¿ ES AUXILIARY DRAWER FAILED AND NOT DETECTED ON THE BINARY UNIFIED SYSTEM. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304126 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown