BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25032712 · Received April 29, 2026

    Report

    Report Number
    2016493-2026-24745
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    August 22, 2025
    Report Date
    April 19, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE DEVICE IDENTIFIER (UDI) NOT AVAILABLE. 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, 02-APR-2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. PART ANALYSIS: THE REPORTED ISSUE DRAWER ISSUE WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FSE ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT DRAWERS 1,2,11 AND 12 YELLOW IN DRAWER CONFIGURATION. THE FSE REPLACED MODULE CONTROLLERS ON BOTH DRAWERS. DCHU VISUAL INSPECTION: P/N 151730-21: RECEIVED PRESENTED A COMPONENT (U501) WITH BLACK MARKS, WHICH INDICATES THAT BOTH BOARDS SUFFERED THERMAL DAMAGE. DCHU LABORATORY INSPECTION: P/N 151730-21: DUE TO THERMAL DAMAGE SUFFERED IN BOTH PARTS RECEIVED (SN: (B)(6) AND SN: (B)(6)) NO FURTHER TESTING WAS DEEMED NECESSARY. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED AS FAULTY PCBA PMC PYXIS MINI FW1-12 DUE TO THERMAL DAMAGE IN THE COMPONENT U501 WHICH COMPROMISES THE PROPER FUNCTIONALITY OF THE WHOLE BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE DRAWER FAILED TO OPEN. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE 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
    16945 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown