BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23092430 · Received September 18, 2025

    Report

    Report Number
    2016493-2025-115565
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 3, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 07-DEC-2017 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 DRAWER BOARD WAS FAILED. A FIELD SERVICE ENGINEER INSPECTED AND RESEATED ALL CABLES, CHECKED SENSORS, AND EXAMINED THE CONTROLLER BOARDS. PART NUMBER 121985-01 WAS REPLACED, BUT THE ISSUE PERSISTED. SUBSEQUENTLY, THE CONTROLLER BOARDS WERE SWAPPED WITH ALTERNATE UNITS, WHICH RESOLVED THE PROBLEM. A DRAWER WAS THEN SUCCESSFULLY ADDED TO THE STORAGE SPACE CONFIGURATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES MATRIX DRAWER BOARD WAS FAILED. 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
    288159 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown