BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER

    MDR report key: 23933210 · Received December 31, 2025

    Report

    Report Number
    2016493-2025-146970
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 25, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    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, 24-FEB-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 DOOR 3 WAS FAILED. A FIELD SERVICE ENGINEER (FSE) HAD A MEDSTATION AND FOUND THAT DOOR 3 WAS NOT DETECTED ON THE DOOR CONTROLLER PRINTED CIRCUIT BOARD (PCB), AS INDICATED BY N/I. THE FSE CHECKED ALL THE ELECTRICAL CONNECTORS IN THE CABINET AND LATCH COLUMN, RETESTED ALL THE HARNESSES TO THE DOOR, RESTARTED THE CONTROLLER PCB, AND THEN TESTED THROUGH THE (HARDWARE TEST APPLICATION) SELF-TEST. 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 AUXILIARY TOWER PATIENT-SPECIFIC DOOR REPEATEDLY FAILED AND THE ISSUE WAS NOTED DURING REPLENISHMENT AND DISPENSING, BUT MEDICATION DELIVERY WAS NOT DELAYED AS BINS WERE RELOCATED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570668 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown