BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 21808035 · Received April 9, 2025

    Report

    Report Number
    2016493-2025-72078
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    December 1, 2022
    Report Date
    April 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INITIAL MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA: 10308384. THE DELAY IN SUBMITTING THIS MDR IS DUE TO 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. AS RECOMMENDED, WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION. A REVIEW OF THE COMPLAINT HISTORY FOR SN: (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 08-NOV-2018 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 DEVICE HAD LOGIN ISSUE DUE TO DATABASE ISSUE. A FIELD SERVICE ENGINEER CLEARED UP SPACE ON C DRIVE AND DATABASE CLEAN AND COMPLETE BTX (BALANCED TECHNOLOGY EXTENDED) 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 WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES SYSTEM NEEDED TO BE RESTARTED EVERY DAY FOR PATIENTS TO SHOW UP AND THE USERS HAD LOGIN ISSUE AS WELL. THE SYSTEM HAD TO BE RESTARTED FOR ALL THE DRAWERS TO BE UNLOCKED. ALSO, IT DID NOT ALLOW ANY PATIENTS TEMP TO BE ADDED AS WELL. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492153 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown