BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 23041782 · Received September 12, 2025

    Report

    Report Number
    2016493-2025-113687
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    February 11, 2022
    Report Date
    September 2, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING JANUARY 2022-DECEMBER 5, 2024, UNDER CAPA 10308384. THE LATE SUBMISSION OF THIS REPORT IS JUSTIFIED BY 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. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER NOT AVAILABLE, THEN COMPLAINT HISTORY REVIEW (CHR) IS NOT REQUIRED. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER NOT AVAILABLE, THEN DEVICE HISTORY REVIEW (DHR) IS NOT REQUIRED. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICE MAIN DRAWER FAILED TO UNLOCK AUTOMATICALLY. A TECHNICAL SUPPORT SPECIALIST FOUND A SECURITY GROUP OF THE ITEMS IN THE BACKEND AND MEDICATION ID 1472 IS LOADED WITH SEVERAL SECURITY GROUPS SUCH AS CHH PARAMEDIC, NON-CONTROLLED AND RESPIRATORY, CHECKED THE SNAPSHOTS FROM THE ITEM.FACILITYSNAPSHOT TABLE, ADDED RESPIRATORY TO THE ACCESS. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOT BY THE TECHNICAL SUPPORT SPECIALIST.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ ANESTHESIA STATION ES MAIN DRAWER FAILED TO UNLOCK AUTOMATICALLY AND WERE UNABLE TO ACCESS ANY MEDS FROM SEVERAL OF THE DEVICES. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655944 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown