BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25067886 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25710
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    December 7, 2025
    Report Date
    April 19, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 A SIMILAR COMPLAINT 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 24FEB2022, 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 "DRAWER 12 NOT RECOGNIZED" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER #(B)(4), THE FSE REPORTED THAT OPENED BACK PANEL AND FOUND POWER GOING TO DRAWER 12 BUT NO COMMUNICATION LIGHTS DISPLAYING. THE FSE REMOVED AND REPLACED DRAWER MODULE BOARD AND REBOOTED DEVICE. AFTER REBOOT CONFIRMED ORANGE COMMUNICATION LIGHTS WERE DISPLAYING. THE FSE CALLED MEDBANK SUPPORT AND SUPPORT WAS ABLE TO RECONFIGURE AND TEST DRAWER REMOTELY WITH GOOD RESULTS. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N 151730-21: BOTH PARTS WERE RECEIVED WITH SIGNS OF THERMAL DAMAGE ON COMPONENT U501. DURING DCHU TESTING: P/N 151730-21: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE SIGNS OF THERMAL ON THE INTERNAL COMPONENT OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198 (D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U501 ON BOTH ¿PCBA PMC PYXIS MINI FW1-12¿ (P/N 151730-21) RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE DRAWER 12 WAS NOT RECOGNIZED AND DRAWERS 08 AND 12 WERE NOT OPENING. THE CUSTOMER ATTEMPTED TO REBOOT THE STATION, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U501. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10295 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown