BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24726738 · Received March 30, 2026

    Report

    Report Number
    2016493-2026-17296
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 13, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, 03-DEC-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 INVOLVED IN THE INCIDENT. IT WAS DETERMINED THAT THE ISSUE HAD BEEN CAUSED BY SUSPECT OR LOOSE CONNECTIONS OF THE RETRACTOR BAND CONNECTORS IN THE DRAWER MODULE WHICH HAD NOT BEEN SNAPPING IN SECURELY AND MAY HAVE CAUSED THE CUBIES TO FAIL AND LOSE THEIR STATE. A FIELD SERVICE ENGINEER DETERMINED THAT THE ISSUE WAS RESOLVED BY RESEATING ALL CONNECTIONS REPLACING THE SUSPECT DRAWER MODULE CONTROLLER AS A PRECAUTION REBOOTING THE UNIT AND TESTING EVERY POCKET TO CONFIRM THAT ALL QBS AND CUBIES FUNCTIONED PROPERLY WITH NO DEBRIS PRESENT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER COMPLETED THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWER 2.1 NOT DETECTED ON BUS, WHICH LOCATED ON RH N5S B. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION, AND THEY WERE UNABLE TO ISSUE THE MEDICATION, WHICH RESULTED IN 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
    791282 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown