BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24672386 · Received March 24, 2026

    Report

    Report Number
    2016493-2026-15862
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 16, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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, 12-JAN-2023 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 SYSTEM HAD PRINTER FAILURE. A FIELD SERVICE ENGINEER CONFIRMED THAT THE WORKSTATION WAS CURRENTLY IN STORAGE WITHIN THE PHARMACY, ALONG WITH A PRINTER INTENDED TO REPLACE A PREVIOUSLY FAILED UNIT. THE FSE CONNECTED THE WORKSTATION, INSTALLED UPDATED DRIVERS, CONFIGURED THE REQUIRED SETTINGS FOR THE MEDICATION APPLICATION, AND PERFORMED TESTING. THE CUSTOMER COMPLETED A PRINT TEST, WHICH PASSED SUCCESSFULLY, CONFIRMING NORMAL OPERATION. 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 PSY MLM ZEBRA PRINTER WOULD NOT TURN ON AT ALL AND REQUIRED REPLACEMENT. THE CUSTOMER ALSO CONFIRMED THAT THE STATION WAS NOT ON THE NETWORK. HOWEVER, THERE WERE NO DELAYS, ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736015 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown