BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 24996620 · Received April 27, 2026

    Report

    Report Number
    2016493-2026-24015
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 12, 2025
    Report Date
    April 24, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR S/N (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 29OCT2018 TO THE PRESENT DATE, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER-REPORTED ISSUE. THE REPORTED CONDITION OF DRAWERS NOT OPENING WAS CONFIRMED DURING FSE TESTING AND VERIFICATION OF THERMAL DAMAGE WAS SUBSEQUENTLY CONFIRMED DURING DCHU INVESTIGATION PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT REPLACED DRAWER CONTROLLER CARD FOR DRAWER 3/4. DURING DCHU VISUAL INSPECTION P/N 151730-21: THE PART RECEIVED PRESENTED A THERMALLY DAMAGED COMPONENT (U501) DUE TO AN OVERCURRENT CONDITION. DURING DCHU TESTING P/N 151730-21: NO DCHU TESTING WAS NECESSARY ON THE "PCBA PMC PYXIS MINI FW1-12" DUE TO THE OBSERVED THERMAL DAMAGE OBSERVED DURING VISUAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE DRAWER 4 STUCK AND FAILED TO OPEN. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U501 OF PCBA PMC PYXIS MINI FW1 12. THERE WERE NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45742 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown