BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23663731 · Received November 27, 2025

    Report

    Report Number
    2016493-2025-138579
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    November 2, 2025
    Report Date
    November 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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, 23-NOV-2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER FAILED. A FIELD SERVICE ENGINEER DISCOVERED THAT DRAWER FIVE DID NOT HAVE ANY LIGHTS ILLUMINATED ON THE MODULE CONTROL BOARD. A FIELD SERVICE ENGINEER TESTED THE DRAWER CONTROLLER TO CONFIRM THAT IT WAS FUNCTIONING PROPERLY AND SUBSEQUENTLY REPLACED THE MODULE CONTROLLER. ADDITIONALLY, DRAWER SIX'S MODULE CONTROLLER ALSO LACKED ILLUMINATION. A FIELD SERVICE ENGINEER TESTED THE DRAWER CONTROLLER TO ENSURE IT WAS OPERATIONAL AND THEN REPLACED THE MODULE CONTROLLER ON THE FULL-HEIGHT DRAWER. DURING THE REPLACEMENT PROCESS, A FIELD SERVICE ENGINEER OBSERVED THAT THE PLASTIC ON THE RETRACTOR BAND WAS DAMAGED AND ALSO REPLACED THE RETRACTOR BAND. IT WAS TESTED IN THE HARDWARE TESTING APPLICATION WITHOUT ENCOUNTERING ANY ISSUES. PROACTIVE INSPECTION PROCESS WAS PERFORMED. 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, DRAWER 5 WAS NOT DETECTED ON THE BUS. AN ATTEMPT WAS MADE TO RECONNECT THE BUS, BUT SPARKS OCCURRED DURING THE PROCESS. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2808170 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown