BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 21682740 · Received March 24, 2025

    Report

    Report Number
    2016493-2025-68392
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MALFUNCTION WAS CAUSED BY READ AND WRITE ERRORS IN MULTIPLE CUBIE POCKETS OF DRAWERS 4.1 AND 4.2. A FIELD SERVICE ENGINEER POWERED DOWN THE STATION AND DISASSEMBLED THE DRAWER ACCORDING TO THE GUIDELINES IN FSG SECTION 3.11.3. WHILE THE DRAWER WAS DISASSEMBLED, THE FIELD SERVICE ENGINEER RECONNECTED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND THE MODULE CONTROLLER. THE ROW BOARD CABLE WAS ALSO RECONNECTED AT THE DRAWER CONTROLLER AND THE INDIVIDUAL ROW BOARDS. AFTER REASSEMBLING THE DRAWER, THE ENGINEER POWERED THE DEVICE BACK ON AND CHECKED THE DRAWER'S FUNCTIONALITY THROUGH DIAGNOSTICS. ALL DRAWERS WERE FUNCTIONING PROPERLY, AND THE STATION WAS HANDED OVER TO THE PHARMACY STAFF FOR TESTING AND CONFIRMING THAT THE ISSUE WAS RESOLVED. DURING THE RECOVERY PROCESS, ALL FAILED CUBIE POCKETS WERE REMOVED, AND MEDICATIONS WERE PLACED INTO NEW POCKETS IN THE STATION. A FIELD SERVICE ENGINEER STATED THAT THERE WAS A DELAY IN THE DISPENSING OF THE MEDICATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY HAD A DRAWER FAILURE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459118 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown