BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 24924114 · Received April 20, 2026

    Report

    Report Number
    2016493-2026-22472
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 24, 2026
    Report Date
    March 29, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    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 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, 04-SEP-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 THE STATION STUCK IN A RESTART LOOP DUE TO WINDOWS UPDATE ISSUES. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE HARD DRIVE AND PERFORMED A FULL SYSTEM REIMAGE TO STATION. ALL REQUIRED UPDATES, DATA SYNC, AND SOFTWARE INSTALLATIONS WERE COMPLETED, AND AUTO-LOGIN WAS ENABLED BEFORE RETURNING THE STATION TO SERVICE. DRAWER 2.1 AND 2.2 ISSUES WERE RESOLVED BY ADJUSTING THE SENSOR MAGNET STRIPS AND GUIDE RAILS, AND THE STATION WAS MOVED BACK TO ITS ORIGINAL LOCATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER (FSE) RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, SOME OF THE DRAWERS DID NOT OPEN AND SOME DID NOT CLOSE. THE PYXIS SYSTEM WAS BEING USED FOR STAT GI CASES. THE CUSTOMER STATED 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
    601097 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown