BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 23047529 · Received September 13, 2025

    Report

    Report Number
    2016493-2025-113887
    Event Type
    Malfunction
    Date Received
    September 13, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 05-NOV-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 USER HAD ISSUES WITH BIO ID LOGIN. A FIELD SERVICE ENGINEER (FSE) IDENTIFIED A BIO ID ISSUE FOLLOWING THE 174 UPDATES, TRACED IT TO A DOWNGRADED DRIVER. THE FSE DIALED INTO THE STATION REMOTELY AND RESOLVED THE PROBLEM BY APPLYING THE DRIVER UPDATE FROM COMMUNICATION BULLETIN 2093. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, USER MENTIONED LOGGING ISSUE WITH BIO IDENTIFICATION AFTER UPDATES. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED WHEN DISPENSING MEDICATIONS TO THE PATIENT WHICH RESULTED IN A DELAY TO THE PATIENT WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, USER MENTIONED LOGGING ISSUE WITH BIO IDENTIFICATION AFTER UPDATES. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668455 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown