BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25093204 · Received May 6, 2026

    Report

    Report Number
    2016493-2026-26293
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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, 16-DEC-2021 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 FULL HEIGHT CUBIE DRAWER NUMBER ONE HAD FAILED AND REQUIRED MAINTENANCE. A FIELD SERVICE ENGINEER INSPECTED THE DRAWERS AND OBSERVED LIGHT EMITTING DIODES (LEDS) ON THE MODULE CONTROLLER WERE NOT ILLUMINATED. FIELD TESTING OF THE DRAWER CONTROLLER SHOWED TP505 AND TP502 RESISTANCE LESS THAN 1K OHMS. REPLACED THE DRAWER CONTROLLER, BUT UPON POWER UP LEDS ON THE MODULE CONTROLLER REMAINED OFF. OBSERVED PYXIBUS MODULE CONTROLLER POWER LIGHT ILLUMINATED, BUT DRAWER STATUS LEDS WERE NOT. REPLACED THE PYXIBUS MODULE CONTROLLER. ALLOWED SYSTEM TO BOOT INTO THE MED APPLICATION, CONFIGURED NEW CONTROLLER, AND PERFORMED FINAL TESTING ALL FUNCTIONS VERIFIED. 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, THE DRAWER HAD FAILED AND WAS UNABLE TO BE RECOVERED. THE CUSTOMER REPORTED 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
    182903 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown