BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22231224 · Received June 17, 2025

    Report

    Report Number
    2016493-2025-87579
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 16, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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-AUG-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 THIS INCIDENT, IT WAS DETERMINED THAT THE REFRIGERATOR WAS NOT AVAILABLE TO SELECT FOR REFILLING, OPENING, OR COUNTING ON THE STATION. THE TECHNICAL SUPPORT SPECIALIST APPLIED KA (ES REFRIGERATOR PROMPTING TO SCAN ON LOAD/REFILL) LOCKING BIN WAS DESIGNED TO FUNCTION AS A MINI TRAY WITH A SINGLE POCKET AND USERS WERE PROMPTED TO SCAN THE STORAGE SPACE WHEN 'SCAN ON LOAD/REFILL' WAS ENABLED. BARCODES HAD TO BE ADDED TO THE REFRIGERATOR TO ACCOMMODATE RESOLVING THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES REFRIGERATOR WAS NOT ABLE TO OPEN USING TNF OPEN FRIDGE. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39248 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown