BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23483533 · Received November 6, 2025

    Report

    Report Number
    2016493-2025-130350
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    August 5, 2024
    Report Date
    October 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER IS NOT AVAILABLE, THEN COMPLAINT HISTORY REVIEW (CHR) IS NOT REQUIRED. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER IS NOT AVAILABLE, THEN DEVICE HISTORY REVIEW (DHR) IS NOT REQUIRED. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THERE WAS A DISK SPACE ISSUE ON L: WHICH WAS PREVENTING USERS TO LOGIN BY W-B3VB-19-PYXTS. A TECHNICAL SUPPORT SPECIALIST MENTIONED THE ISSUE WAS RESOLVED ALREADY AND UNABLE TO REPLICATE THE REPORTED ISSUE; NO ISSUE FOUND. THE TECHNICIAN INFORMED CUSTOMER THAT IN ORDER TO BE ABLE TO LOGIN TO THE SERVERS, CUSTOMER NEEDED TO REACH OUT WITH THEIR HOSPITAL IT. 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 PYXIS ES IT INFRASTRUCTURE ALL USER WAS UNABLE TO LOGIN SERVER AND CUSTOMER REQUESTED URGENT ASSISTANCE ON THE ISSUE SINCE IT WAS IMPACTING PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280565 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 1115-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown