BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23670155 · Received November 28, 2025

    Report

    Report Number
    2016493-2025-138960
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 8, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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, 24-JUL-2024 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 IN THIS INCIDENT, IT WAS DETERMINED THAT THE PATIENT WAS NOT SHOWING UP ON 1 STATION. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE SERVER AND RAN A PATIENT CAST QUERY FOR THE AFFECTED PATIENT. TSS FOUND THAT THE PATIENT WENT TO LEAVE ON ABSENCE (LOA) STATUS AND RECEIVED XML CODE 'TRANSFER'. TSS REACHED OUT TO INTERFACE ENGINEER (IE) FOR ADVICE ON CARE FUSION COORDINATION ENGINE (CCE) MESSAGES IE ADVISED THAT ONCE A PATIENT GOES TO LOA STATUS, THE HOSPITAL INTERFACE NEEDS TO SEND AN A22 MESSAGE TO READMIT THE PATIENT FROM LOA. TSS SENT A GUIDE TO THE CUSTOMER VIA EMAIL AND ADVISED TO CONTACT THEIR HOSPITAL INTERFACE TEAM TO SEND THE CORRECT HL7 MESSAGE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES PATIENT WAS NOT SHOWING UP AND THERE WAS NO MEDICATION PROFILE FOR THE NURSES. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093647 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown