BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS MEDSTATION ES (MAIN)

    MDR report key: 21046832 · Received December 31, 2024

    Report

    Report Number
    2016493-2024-01461
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 4, 2024
    Report Date
    March 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM 05-DEC-2022 TO 04-DEC-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 USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE ISSUE IS NOT SOFTWARE RELATED AND MORE ON HARDWARE ISSUE. THE TECHNICAL SUPPORT SPECIALIST DIALED INTO THE STATION AND FOUND THAT THERE WAS NO FAILED DRAWER DETECTED ON THE STATION AND THERE WAS NO DUPLICATE ADDRESS ERROR, ALSO CHECKED HSV AND NO ERROR OR FAILED HARDWARE NOTICE FOR STATION 5W0M-PYX. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT STATION HAS DUPLICATE ADDRESS. A TECHNICAL SERVICE SPECIALIST CONFIRMED THAT THERE IS NO ISSUE FOUND. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOOTING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE PYXIS MEDSTATION ES SYSTEM HAS DUPLICATE ADDRESS. THE CUSTOMER CONFIRMED THAT THERE WAS DELAY OCCURRED DUE TO THE REPORTED MALFUNCTION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE PYXIS MEDSTATION ES SYSTEM HAS DUPLICATE ADDRESS. THE CUSTOMER CONFIRMED THAT THERE WAS DELAY OCCURRED DUE TO THE REPORTED MALFUNCTION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253423 BD PYXIS MEDSTATION ES (MAIN) AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown