BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23526177 · Received November 11, 2025

    Report

    Report Number
    2016493-2025-133233
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    July 28, 2025
    Report Date
    December 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI). A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 15-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 STATION DID NOT ALERT OR CREATE A DISCREPANCY WHEN AN ADDITIONAL DOSE WAS REMOVED. THE TECHNICAL SUPPORT SPECIALIST (TSS) INVESTIGATION FOCUSED ON VALIDATING THE CUSTOMER CLAIM AND REVIEWING SYSTEM BEHAVIOR. THE STATION INVOLVED WAS CONFIRMED AS PROFILE STATION, AND THE MEDICATION WAS METHADONE 40 MG. DATABASE QUERIES SHOWED TWO TRANSACTIONS FOR THE SAME ORDER WITHIN 16 MINUTES, INDICATING THAT A SECOND DOSE WAS REMOVED SHORTLY AFTER THE FIRST. FACILITY ITEM SETTINGS REVEALED THAT THE TOOCLOSEREMOVEDURATIONAMOUNT WAS NEVER CONFIGURED, ALTHOUGH THE STATION HAD THE TOOCLOSEWARNINGFLAG ENABLED. LOGS CONFIRMED THAT DURING THE SECOND LOGIN SESSION, THE FUTUREDURATIONWARNINGVIEWMODEL SCREEN APPEARED, WHICH PROMPTS THE USER WHEN A SECOND DOSE IS BEING REMOVED. ADDITIONAL ACTIONS INCLUDED CREATING A STATION DATABASE BACKUP, GENERATING DEVICE EVENT REPORTS, COLLECTING SYSTEM LOGS, AND ESCALATING FINDINGS TO THE PRODUCT SUPPORT ENGINEER TEAM FOR REVIEW. NO CONFIGURATION CHANGES WERE APPLIED, AND THE EVENT WAS ATTRIBUTED TO USER OVERRIDE DESPITE THE WARNING BEING DISPLAYED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE MORNING MEDICATION PASS (MEDPASS), A CLINICIAN RETRIEVED METHADONE 40 MG FROM BD PYXIS¿ MEDSTATION¿ ES UNDER THE CORRECT PATIENT¿S NAME AND ADMINISTERED IT TO A PATIENT. A FEW MINUTES LATER, ANOTHER PATIENT APPROACHED THE CLINICIAN, STATING THEY HAD NOT YET RECEIVED THEIR METHADONE DOSE. UPON REVIEWING THE SITUATION, THE CLINICIAN REALIZED THE MEDICATION HAD BEEN GIVEN TO THE INCORRECT PATIENT. THE CLINICIAN THEN RETURNED TO THE BD PYXIS¿ MEDSTATION¿ ES, OVERRODE THE SYSTEM TO OBTAIN ANOTHER DOSE OF METHADONE 40 MG, AND ADMINISTERED IT TO THE INTENDED PATIENT. SHORTLY THEREAFTER, THE CLINICIAN RETURNED TO CHECK ON THE PATIENT WHO HAD MISTAKENLY RECEIVED THE METHADONE AND FOUND THEM UNRESPONSIVE. A CODE WAS INITIATED, AND THE PATIENT WAS TRANSFERRED TO AN ACUTE CARE FACILITY. THE PATIENT WAS REPORTED TO HAVE EXPIRED ON (B)(6) 2025, AT APPROXIMATELY 9:00 AM. IT WAS REPORTED THAT THE AUTOPSY REPORT SHOWED METHADONE IN THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE MORNING MEDICATION PASS (¿MEDPASS¿), A CLINICIAN RETRIEVED METHADONE 40 MG FROM THE PYXIS MEDSTATION ES UNDER THE CORRECT PATIENT¿S NAME AND ADMINISTERED IT TO A PATIENT. A FEW MINUTES LATER, ANOTHER PATIENT APPROACHED THE CLINICIAN, STATING THEY HAD NOT YET RECEIVED THEIR METHADONE DOSE. UPON REVIEWING THE SITUATION, THE CLINICIAN REALIZED THE MEDICATION HAD BEEN GIVEN TO THE INCORRECT PATIENT. THE CLINICIAN THEN RETURNED TO THE PYXIS MEDSTATION ES, OVERRODE THE SYSTEM TO OBTAIN ANOTHER DOSE OF METHADONE 40 MG, AND ADMINISTERED IT TO THE INTENDED PATIENT. SHORTLY THEREAFTER, THE CLINICIAN RETURNED TO CHECK ON THE PATIENT WHO HAD MISTAKENLY RECEIVED THE METHADONE AND FOUND THEM UNRESPONSIVE. A CODE WAS INITIATED, AND THE PATIENT WAS TRANSFERRED TO AN ACUTE CARE FACILITY. THE PATIENT WAS REPORTED TO HAVE EXPIRED ON (B)(6) 2025, AT APPROXIMATELY 9:00 AM. IT WAS REPORTED THAT THE AUTOPSY REPORT SHOWED METHADONE IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933738 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Death