BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 24725140 · Received March 30, 2026

    Report

    Report Number
    2016493-2026-17167
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 10, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, 25-JUL-2022 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 DEVICE HALF HEIGHT DRAWER (BOTTOM HALF) WAS NOT WORKING. THE FIELD SERVICE ENGINEER (FSE) POWERED DOWN THE STATION AND THEN POWERED IT BACK UP IN SUPPORT. THE FSE OPENED THE HARDWARE TEST APPLICATION (HTA) AND TESTED THE DRAWER, FINDING THAT ALL THE CUBIES WERE GREYED OUT AND COULD NOT BE SELECTED. BASED ON EXPERIENCE, THE FSE RESEATED THE RETRACTOR BAND, AS IT IS THE WEAKEST LINK IN THE CIRCUIT. THE FSE POWERED DOWN THE STATION AGAIN AND RESEATED THE RETRACTOR CABLE TO RESOLVE THE ISSUE. AFTER POWERING THE STATION BACK UP IN SUPPORT, THE FSE TESTED ALL POCKETS AND THE DRAWER IN THE HTA. 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 OGB-2 HALF-HEIGHT DRAWERS 5.1 AND 5.2 PARTICULARLY 5.2 HAVE EXPERIENCED INTERMITTENT CUBIE FAILURES. MULTIPLE LOCATIONS NOW APPEARED AS NOT DETECTED ON BUS, AND AT TIMES THE ENTIRE 5.2 DRAWER FAILED. THE MACHINE HAD BEEN RESTARTED FREQUENTLY, AND STAFF HAD TO RELOCATE ALL MEDICATIONS FROM THIS DRAWER SO NURSES COULD ACCESS IT. 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
    785105 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown