BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22772195 · Received August 11, 2025

    Report

    Report Number
    2016493-2025-104072
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 15, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHARMACIST
    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, 31-AUG-2020 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 THE INCIDENT, IT WAS DETERMINED THAT THE LOA STATUS WAS NOT BEING REMOVED. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE PRODUCTION SERVER AND PERFORMED SEVERAL CHECKS. THE DOWNTIME QUERY WAS RUN, CONFIRMING THAT NO CAREFUSION COORDINATION ENGINE AND ACTIVE DIRECTORY MESSAGES WERE STUCK IN THE ES SERVER POOL. THEN, A PATIENT ENCOUNTER QUERY WAS EXECUTED, WHICH SHOWED THAT THE PATIENT HAD BEEN MOVED OUT OF LOA BUT WAS PLACED BACK INTO LOA A FEW SECONDS LATER. THE TSS LOGGED INTO PES AND VERIFIED THAT THE PATIENT WAS STILL IN LOA STATUS. THE TSS DIALED INTO THE PRODUCTION SERVER AGAIN, OPENED STRUCTURED QUERY LANGUAGE SERVER MANAGEMENT STUDIO, AND RE-RAN THE QUERY TO CHECK THE PATIENT STATUS. IT WAS VERIFIED THAT THE PATIENT HAD BEEN MOVED OUT OF LOA. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NO LONGER IN LOA STATUS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES THE PATIENT MESSAGE WAS NOT SENT TO PYXIS IN ORDER TO ALLOW MEDS TO BE REMOVED FOR THAT VISIT. THE CUSTOMER STATED THAT THERE WAS A DELAY IN ACCESSING MEDICATION TO PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES THE PATIENT MESSAGE WAS NOT SENT TO PYXIS IN ORDER TO ALLOW MEDS TO BE REMOVED FOR THAT VISIT. THE CUSTOMER STATED THAT THERE WAS A DELAY IN ACCESSING MEDICATION TO PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183392 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown