BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25263769 · Received May 23, 2026

    Report

    Report Number
    2016493-2026-31383
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 1, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, 11-MAR-2020 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 STATION POWER SUPPLY MODULE WAS FAULTY. A FIELD SERVICE ENGINEER FOUND THE POWER SUPPLY WAS SHUNTING UNDER LOAD WITH ALL PERIPHERALS CONNECTED. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. 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 UC-JBS STATION INTERMITTENTLY POWERED OFF AND RESTARTED INTO MAINTENANCE MODE, WHERE RECOVERY ATTEMPTS FAILED. AN ERROR MESSAGE 0XC0001-PRESS TRY AGAIN, AC POWER FAILED DISPLAYED ON THE SCREEN. THE CUSTOMER HAD ATTEMPTED MULTIPLE REBOOTS AND RECOVERY ACTIONS; HOWEVER, THE ISSUE PERSISTS AND THE STATION REMAINS NON-FUNCTIONAL. THE CUSTOMER STATED THAT THERE WAS 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
    527162 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1