BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25017328 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24453
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    October 31, 2025
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403517167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, 26-DEC-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. PART ANALYSIS: THE REPORTED ISSUE UNABLE TO CYCLE COUNT WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FSE ACCORDING TO WORK ORDER 02181613, THE FSE REPORTED THAT IT REPLACED PMC BOARD. ASSISTED BY MEDBANK AGENT TO UPDATE ZONE 11 IN APP. DCHU VISUAL INSPECTION: PCBA PMC PYXIS MINI FW1-12, P/N 151730-21 RECEIVED PRESENTED A COMPONENT (U501) WITH BLACK MARKS, WHICH INDICATES THAT BOARD SUFFERED A THERMAL DAMAGE. DCHU LABORATORY INSPECTION: DUE TO EVIDENT THERMAL DAMAGE IN THE PCBA PMC PYXIS MINI FW1-12 (P/N 151730-21) 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 COMPLAINT PCBA PMC PYXIS MINI FW1-12 WAS DETERMINED TO BE DUE TO A DAMAGED COMPONENT U501. VISUAL INSPECTION OF THE COMPONENT SHOWED EVIDENCE OF THE THERMAL DAMAGE AND COMPROMISED THE DRAWER'S FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE MATRIX DRAWER 11 FAILED AND UNABLE TO DO CYCLE COUNT. THE CUSTOMER ATTEMPTED TO RESTART THE STATION, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA PMC PYXIS MINI FW1-12. THERE WAS NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93161 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown