BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN

    MDR report key: 24128455 · Received January 21, 2026

    Report

    Report Number
    2016493-2026-01237
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 3, 2026
    Report Date
    January 10, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512636
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    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, 22-JAN-2011 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 ISSUE WAS WITH OLD STYLE RETRACTOR BAND OR OLD-STYLE POSITIONING SENSOR INTO THE MOTHERBOARD. A FIELD SERVICE ENGINEER CHECKED AND RESEATED ALL CONNECTIONS AND CLEARED THE LINER OF DEBRIS TO RESOLVE THE ISSUE. THE FSE HAD PERFORMED TESTING IN THE HARDWARE TEST APPLICATION, BUT THERE WAS NO LOG FILE AVAILABLE TO CAPTURE A PICTURE OF THE HTA. THE DRAWER WAS RECOVERED BY THE CUSTOMER IN THE APPLICATION, AND RANDOM MEDICATIONS WERE INVENTORIED SUCCESSFULLY. 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 THEBD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN WHEN USER WAS ACCESSING MEDICATIONS IN DRAWER 8.2 IN PYXED, A MESSAGE TO PLEASE OPEN DRAWER WAS DISPLAYED AND WOULD NOT GO AWAY EVEN WHEN THE DRAWER WAS ALL THE WAY OPEN. EVEN CLOSING THE DRAWER DID NOT HELP, AS IT JUST POPPED BACK OPEN. THE MESSAGE ON THE SCREEN WOULD NOT GO AWAY AND THE MACHINE HAD TO BE POWERED DOWN AND REBOOTED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191577 BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002002 10885403512636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown