BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 21886115 · Received April 22, 2025

    Report

    Report Number
    2016493-2025-75297
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 21, 2025
    Report Date
    April 22, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    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 SERIAL NUMBER (B)(6) WAS CONDUCTED IN SALESFORCE. THIS REVIEW DID NOT REVEAL ANY SIMILAR COMPLAINTS ASSOCIATED WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR S/N (B)(6) WAS CONDUCTED FROM ITS MANUFACTURE DATE OF 30 MARCH 2021 TO 11 APRIL 2025. THIS REVIEW CONFIRMED THAT THE DEVICE HAS NOT BEEN RETURNED FOR SERVICING AND THAT THERE WAS NO PRODUCTION FAILURES ASSOCIATED WITH IT THAT WOULD CORRELATE WITH THE CUSTOMER-REPORTED ISSUE. THE REPORTED EVENT, WHERE THE MEDES STATION FAILED TO BOOT UP, WAS CONFIRMED BY THE BD FIELD SERVICE ENGINEER (FSE) DURING THE SITE VISIT. AN INSPECTION OF THE DRAWER CONTROLLER BOARD IN THE DCHU INVESTIGATION LAB REVEALED THAT A THERMAL EVENT HAD AFFECTED THE C507 CAPACITOR. BASED ON THE FIELD SERVICE ENGINEER (FSE) NOTES ON WORK ORDER (WO) 1811035, THE MEDSTATION WAS NOT BOOTING UP UPON THE FSE'S ARRIVAL ON SITE. DURING TROUBLESHOOTING, THE FSE IDENTIFIED A FAULTY DRAWER CONTROLLER BOARD, WHICH WAS SUBSEQUENTLY REPLACED AND TESTED. THE INSPECTION PROCESS PERFORMED ON THE DRAWER CONTROLLER BOARD FOUND EVIDENCE OF A THERMAL DAMAGE ON THE U302 MICROCHIP AND THE C507 CAPACITOR. LABORATORY TESTING WAS NOT PERFORMED BY INSTALLING THE DRAWER CONTROLLER BOARD INTO A MEDSTATION ES IN THE DCHU LAB DUE TO THE BOARD¿S CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY DOES NOT BOOT UP. A HARD REBOOT WAS ATTEMPTED, BUT THE STATION REMAINS UNRESPONSIVE AND FAILS TO START UP. THERE WAS NO IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560487 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown