BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23391051 · Received October 27, 2025

    Report

    Report Number
    2016493-2025-126626
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    February 9, 2024
    Report Date
    October 6, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (B)(6) 2022- (B)(6) 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 2 SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. CASE: (B)(4) ¿ HNT-5N REPEATED DRAW FAILURES AND MACHINE REPEATED DOES NOT REBOOT AND PROGRAM DOES NOT OPEN. WE NEED A TECHNICIAN TO COME IN AND FIX THE MACHINE. THIS IS NOT DAY 2 WITH NO CALL FROM THE PYXIS TECHNICIAN THIS IS NOT ACCEPTABLE. CASE: (B)(4)¿ MS4000 : HNT-5N HAS REPEATED DRAW FAILURES AND MACHINE REPEATED DOES NOT REBOOT AND PROGRAM DOES NOT OPEN. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 09-SEP-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 SYSTEM KEEPS FREEZING AND DISPLAYS A WHITE SCREEN WITH EACH ACTION. A FIELD SERVICE ENGINEER WAS DISPATCHED TO CHECK ON DEVICE POWER SETTINGS AND POSSIBLY REIMAGE THE SYSTEM BASED ON MULTIPLE ERRORS FOUND IN THE EVENT VIEWER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS MEDSTATION ES SYSTEM KEEPS FREEZING, DISPLAYS A WHITE SCREEN WITH EACH ACTION AND TIMES OUT WHEN PULLING OR RESTOCKING MEDICATIONS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308328 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown