BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23155261 · Received September 26, 2025

    Report

    Report Number
    2016493-2025-117856
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    July 11, 2024
    Report Date
    September 23, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LOCATE 3 SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. CASE: (B)(4) ¿ DRAWER FAILURE ONC CL. CASE: (B)(4) ¿ MEDSTATION ES - ONCCLINIC DRAWER FAILED. CASE: (B)(4) ¿ ONCO DRAWER FAILS DAILY. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN: (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 06-NOV-2023 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 DRAWER WAS HAVING TO BE REBOOTED SEVERAL TIMES DURING THE DAY. A FIELD SERVICE ENGINEER WAS DISPATCHED, BUT THE ISSUE WAS RESOLVED BY CUSTOMER BEFORE THE ENGINEER'S ARRIVAL. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS MEDSTATION ES SYSTEM DRAWER 3.1 WAS NOT WORKING AND REQUIRED MAINTENANCE. THE DRAWER REBOOTED SEVERAL TIMES DURING THE DAY USERS WERE FAILED TO GET MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316800 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown