BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ 4000

    MDR report key: 22937304 · Received September 2, 2025

    Report

    Report Number
    2016493-2025-109973
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    April 4, 2023
    Report Date
    August 29, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512629
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    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 26-FEB-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 DEVICE EXPERIENCED A DRAWER FAILURE AND REQUIRED MAINTENANCE. A FIELD SERVICE ENGINEER FOUND LEGACY HALF-HEIGHT DRAWERS FAILED WITH MAINTENANCE REQUIRED. ON ARRIVAL, THE APPLICATION WAS NOT BOOTED. ONCE LOADED, NO DRAWER FAILURES WERE VISIBLE. AFTER CHECKING ALL FOUR DRAWERS, DRAWER 2.1 WAS FOUND WITH A BROKEN RETRACTOR BAND. REPLACED THE BAND (PART #122275-01). CUSTOMER CONFIRMED PROPER FUNCTIONALITY 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 A BD PYXIS¿ MEDSTATION¿ 4000 DRAWERS FAILED REPEATEDLY DESPITE MULTIPLE RECOVERY ATTEMPTS, PREVENTING NURSES FROM ACCESSING MEDICATIONS. LEGACY HALF-HEIGHT DRAWERS HAD MAINTENANCE ISSUES AND DID NOT RECOVER. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890516 BD PYXIS¿ MEDSTATION¿ 4000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 303 10885403512629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown