BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 23630242 · Received November 24, 2025

    Report

    Report Number
    2016493-2025-137516
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 1, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 09-OCT-2024 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 WAS EXPERIENCING LOGIN ISSUES. A TECHNICAL SUPPORT SPECIALIST (TSS) DISCUSSED THE CUSTOMER GOAL AND VERIFIED WHETHER THE REQUIRED INFORMATION COULD BE ACCESSED THROUGH EXISTING REPORTS OR THE KNOWLEDGE PORTAL (KP). THEY CONFIRMED THAT IF THE REPORT WAS AVAILABLE, THEY GUIDED THE CUSTOMER ON HOW TO ACCESS IT AND SUGGESTED EXPORTING OR FORMATTING DATA IN EXCEL WHEN NEEDED. WHEN KP WAS INVOLVED, THE TSS EITHER CONNECTED THE CUSTOMER WITH SALES FOR INSTALLATION OR ASSIGNED THE CASE TO A KP AGENT FOR ASSISTANCE. IF THE CUSTOMER REFERENCED A PREVIOUS CUSTOM REPORT, THE TSS REQUESTED THE CASE NUMBER AND SAMPLE FILE, FULFILLED THE REQUEST, AND PROVIDED INSTRUCTIONS FOR SUBMITTING AN ENHANCEMENT REQUEST. FOR FIRST-TIME CUSTOM REPORT REQUESTS, THEY EXPLAINED THE POLICY AGAINST CREATING CUSTOM REPORTS AND SHARED THE ENHANCEMENT REQUEST PROCESS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTS THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, THE USER REQUESTED LOGIN AND LOGOUT ACTIVITY DATA. HOWEVER, THE REQUESTED DATA WAS UNAVAILABLE BECAUSE IT WAS OLDER THAN 90 DAYS. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN 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
    2556096 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown