BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22904018 · Received August 27, 2025

    Report

    Report Number
    2016493-2025-108569
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    November 27, 2023
    Report Date
    August 19, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE 9-DEC-2014 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 CUBIE ON THE MEDSTATION WAS STUCK, AFFECTING A HIGH IMPORTANCE DRAWER THAT HOLDS KEYS TO THE ADDICTIVE DRUGS CABINET. A TECHNICAL SUPPORT SPECIALIST FOUND THAT AGILITY JOB 7914695 WAS SUBMITTED ON (B)(6) 2023 AT 2:29:12 PM, STARTED AT 3:29:12 PM, AND COMPLETED AT 4:29:12 PM. THE SERVICE REQUEST WAS FULFILLED, AND THE CASE WAS CLOSED. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOT BY THE TECHNICAL SUPPORT SPECIALIST.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD PYXIS¿ MEDSTATION¿ ES CUBIE WAS STUCK. THE AFFECTED DRAWER WAS OF HIGH IMPORTANCE, CONTAINED KEYS TO THE CONTROLLED SUBSTANCES CABINET. PATIENTS WERE IMPACTED, AND NO ACCEPTABLE WORKAROUND WAS AVAILABLE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107844 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown