BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 22530652 · Received July 17, 2025

    Report

    Report Number
    2016493-2025-97584
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 20, 2025
    Report Date
    October 24, 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, 30-APR-2025 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 BAD RAILS DRAWER 5. THE TECHNICAL SUPPORT SPECIALIST BEGAN BY REVIEWING THE DEVICE AREA ASSIGNMENTS (E.G., GAR-GI-1), WHICH INCLUDED DMCB-ANES AND DMCG-PROC. USER ROLES AND AREA ASSIGNMENTS FOR USERS K111523 AND H007539 WERE VERIFIED; BOTH HAD THE REGISTERED NURSE - PROCEDURE SUITE ROLE UNDER DOWNEY MEDICAL CENTER WITH ACCESS PATIENT CASE AND REMOVE PERMISSIONS ON ALL SECURITY GROUPS. NO RESTRICTIONS WERE FOUND PREVENTING PATIENT VISIBILITY OR ITEM REMOVAL. CONTACTED PHARMACIST FOR CLARIFICATION; INDICATED THE ISSUE WAS LIKELY ALREADY RESOLVED BUT WAS UNSURE OF THE SPECIFICS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES USER CAN LOGIN INTO THE ANESTHESIA OPEN PROFILE, BUT THEY DO NOT HAVE THE OPTIONS TO PULL THE MEDICATIONS. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES USER CAN LOGIN INTO THE ANESTHESIA OPEN PROFILE, BUT THEY DO NOT HAVE THE OPTIONS TO PULL THE MEDICATIONS. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913938 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown