BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25250948 · Received May 22, 2026

    Report

    Report Number
    2016493-2026-31008
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 2, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, 20-MAY-2019 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 MATRIX DRAWER WAS NOT OPENING. A FIELD SERVICE ENGINEER POWERED DOWN THE STATION AND REMOVED THE BACK PANEL AND FOUND THE U LINK PLUNGER WAS BROKEN. REMOVED THE DRAWER FROM THE CABINET, REPLACED THE PLUNGER, REINSTALLED THE DRAWER INTO THE STATION, CLOSED THE BACK PANEL, AND POWERED THE STATION BACK ON. 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 MBU MAIN DRAWER 1 WOULD NOT OPEN FOR DISPENSING OR RECOVERY. THE CUSTOMER OPENED THE BACK OF THE UNIT AND WAS ABLE TO PUSH THE DRAWER OUT USING THE RED TAB, WITH NO OBSTRUCTIONS OR SCRAPING OBSERVED DURING OPENING. THE CUSTOMER ALSO REBOOTED AND PERFORMED A FULL POWER CYCLE; HOWEVER, NEITHER ACTION RESOLVED THE ISSUE. 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
    236432 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1