BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER

    MDR report key: 23066158 · Received September 16, 2025

    Report

    Report Number
    2016493-2025-114557
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 3, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, 05-AUG-2020 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 CERTAIN COMBO MEDICATIONS WITH BOTH MED AND NON-MED COMPONENTS DID NOT OPEN BOTH CUBIES WHEN THE NURSE ATTEMPTED AN OVERRIDE. A TECHNICAL SUPPORT SPECIALIST EXPLAINED TO THE CUSTOMER THAT MEDICATIONS ORDERED AND REMOVED FROM STATIONS COULD BE CONFIGURED USING ONE OR MORE MEDICATION COMPONENTS. CLARIFIED THAT THE ORDERED COMBO MEDICATION MAY NOT BE A REAL DRUG, BUT ALL COMPONENTS MUST BE IN THE FACILITY'S FORMULARY. PROVIDED STEPS TO SUBMIT AN ENHANCEMENT REQUEST AS PER THEIR REQUEST. THE SYSTEM FUNCTIONED AS INTENDED AFTER TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER, CERTAIN COMBO MEDICATIONS WITH BOTH MED AND NON-MED COMPONENTS DID NOT OPEN BOTH CUBIES WHEN THE NURSE ATTEMPTED AN OVERRIDE. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650629 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown