BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23743507 · Received December 8, 2025

    Report

    Report Number
    2016493-2025-141529
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 19, 2025
    Report Date
    April 15, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: EXEC INVESTIGATION SUMMARY THE REPORTED CONDITION OF FAILED FULL HEIGHT DRAWERS WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER # (B)(4), THE FSE REPORTED THAT IT WAS VERIFIED ISSUE IN HTA, THE FSE OPENED CABINET WHILE POWERED ON, AND THERE WERE NO LIGHTS ON THE AUX DRAWER 1 BUS PCBA, RIGHT LIGHT ON THE MAIN DRAWER 6 WAS FLASHING. POWERED OFF STATION, REPLACED THE BUS PCBA ON AUX1. THE FSE POWERED ON AND HAD LIGHTS ON ALL DRAWERS BUT STILL HAD FAILED STORAGE SPACE ON MAIN 6. THE FSE POWERED OFF, RESEATED BUS CABLE ON MAIN 6. THE FSE POWERED ON AND THE CUSTOMER RECOVERED FAILED SPACE. AFTER REBOOTING, THE DRAWER HAD NO ERRORS. DURING DCHU VISUAL INSPECTION: P/N 151903-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE ON COMPONENT U300. DURING DCHU TESTING: P/N 151903-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE SIGNS OF THERMAL ON INTERNAL COMPONENTS OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U300 ON THE FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 07-MAY-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 DRAWER FAILED. THE FIELD SERVICE ENGINEER (FSE) POWERED OFF STATION AND THE BUS PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) ON AUXILIARY DRAWER 1 WAS REPLACED. AFTER POWERING ON, LIGHTS WERE RESTORED ON ALL DRAWERS, BUT MAIN DRAWER 6 STILL SHOWED A FAILED STORAGE SPACE. THE STATION WAS POWERED OFF AGAIN, AND THE BUS CABLE ON MAIN DRAWER 6 WAS RESEATED. AFTER REBOOTING, THE CUSTOMER RECOVERED THE FAILED SPACE, AND NO ERRORS WERE OBSERVED. THE HARDWARE TEST APPLICATION CONFIRMED PROPER 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 AUXILIARY HAD A DRAWER FAILURE AND NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 OF FULL HEIGHT CUBIE PMC CIRCUIT BOARD. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY HAD A DRAWER FAILURE AND NOT DETECTED ON BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH 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
    319560 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown