BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 23553637 · Received November 14, 2025

    Report

    Report Number
    2016493-2025-135227
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 17, 2025
    Report Date
    October 27, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE DEVICE IDENTIFIER NOT AVAILABLE. 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, 18-SEP-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 IN THIS INCIDENT. IT WAS DETERMINED THAT THE NURSES HAD BEEN ATTEMPTING TO PULL THE PRN DOSE BUT ENCOUNTERED AN ISSUE. A TECHNICAL SUPPORT SPECIALIST (TSS) HAD REVIEWED THE SAMPLE ORDER AND VERIFIED THAT THE REPEAT PATTERN CODE EXISTED IN THE EXTERNAL ORDER FREQUENCY CODES SETTING AND WAS MAPPED CORRECTLY TO QHS AND CONFIRMED THAT THE ORDER HAD CROSSED OVER AND THAT THE ORDER WAS SENT AS PRN QHS WITH A DUE TIME OF 21:00, SO THE ORDER SHOULD HAVE BEEN AVAILABLE FOR THE NURSE TO PULL. THE TSS ALSO NOTICED THAT THE STATION HAD REMOVE BEFORE ORDER START/END CONFIGURED FOR THE STATION, WHICH AFFECTED HOW THE ORDER WAS DISPLAYED. THE TSS ADVISED THE USER TO MAP THE ORDER TO A DIFFERENT FREQUENCY CODE THAT ALIGNED WITH THE DESIRED TIME WINDOW OR EXTEND THE REMOVE AFTER ORDER EXPIRED TIME TO 360 MINUTES (6 HOURS) OR MORE SO THE DOSE WOULD REMAIN AVAILABLE LONGER, WHICH WOULD MAKE A DIFFERENCE. CUSTOMER REPLIED TO TSS PATIENT HAD BEEN DISCHARGED, SO THIS SPECIFIC CASE WAS NO LONGER AN ISSUE. 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¿ ES SERVER HAD PREVENTED ACCESS TO A PRN DOSE AND FAILED TO RELEASE THE MEDICATION. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922911 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown