BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24118144 · Received January 20, 2026

    Report

    Report Number
    2016493-2026-01145
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 2, 2026
    Report Date
    January 10, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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-2022 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 BIOMETRIC IDENTIFIER HAD NEEDED MAINTENANCE, REQUIRING USERS TO LOG IN WITH A PASSWORD AND WITNESS. THE FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE STATION AND HAD THE CUSTOMER ATTEMPT TO LOG IN USING THE BIOMETRIC IDENTIFIER. THE FSE THEN OPENED THE E COMPARTMENT AND RESEATED ALL CONNECTIONS TO THE DOCKING BOARD. AFTER THAT, THE FSE LOGGED INTO THE HARDWARE TEST APPLICATION AND CHECKED THE FIRMWARE FOR ANY UPDATES. RESTARTED THE SYSTEM. THE FSE HAD THE CUSTOMER LOG IN WITH THE BIOMETRIC IDENTIFIER TO CONFIRM THAT IT WAS FUNCTIONING PROPERLY. 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, POD AD MACHINE WITH BIO-IDENTIFICATION DISPLAYED THE ERROR: BIO-ID DEVICE REQUIRED MAINTENANCE. DEVICE ACCESS USING PASSWORD REQUIRED WITNESS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
    183781 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown