BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24219317 · Received January 30, 2026

    Report

    Report Number
    2016493-2026-03092
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 21, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-JUN-2014 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM HAD A DRAWER FAILURE. A FIELD SERVICE ENGINEER FOUND THAT DRAWER 3.1 HAD FAILED, AND THE LIGHT EMITTING DIODES ON THE MODULE CONTROLLER WERE OFF. THE FSE REPLACED THE MODULE CONTROLLER, DRAWER CONTROLLER, AND POSITION SENSOR, AND THEN TESTED THE SYSTEM USING BOTH THE HARDWARE TEST APPLICATION AND THE DISPENSING APPLICATION. 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, HALF HEIGHT CUBIE DRAWERS AND CUBIES WERE NOT DETECTED ON BUS AND UNABLE TO RECOVER, WHICH LOCATED ON LDW. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284131 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown