BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23690552 · Received December 2, 2025

    Report

    Report Number
    2016493-2025-139712
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 8, 2025
    Report Date
    November 14, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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, 23-SEP-2021 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 DUPLICATE CUBIE ADDRESS. A FIELD SERVICE ENGINEER (FSE) INSPECTED THE DRAWER AND FOUND A FAULTY ROW TRAY IN THE A SLOT. FSE POWERED THE STATION DOWN AND DISASSEMBLED THE DRAWER FOLLOWING THE INSTRUCTIONS IDENTIFIED IN FSG SECTION 3.11.3. FSE REPLACED THE HALF-HEIGHT ROW TRAY. WHILE THE DRAWER WAS DISASSEMBLED, FSE RESEATED THE ROW TRAY AND RESEATED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND MODULE CONTROLLER. FSE ALSO RESEATED THE ROW BOARD CABLE AT THE DRAWER CONTROLLER AND THE INDIVIDUAL ROW BOARDS. FSE REASSEMBLED THE DRAWER, POWERED THE DEVICE ON, AND VERIFIED DRAWER FUNCTIONALITY IN DIAGNOSTICS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES HAD CUBIE FAILURE AND DUPLICATE ADDRESSES DETECTED DURING RECOVERY. THE CUSTOMER REPORTED 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
    2809520 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown