BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25079406 · Received May 5, 2026

    Report

    Report Number
    2016493-2026-25988
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    November 13, 2025
    Report Date
    April 19, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403517167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, 06-JAN-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: EXEC INVESTIGATION SUMMARY: THE REPORTED CONDITION OF DRAWER NOT OPENING WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER (B)(4) THE FSE REPORTED THAT OBSERVED INCORRECT LED LIGHTING ON THE PYXIBUS MODULE CONTROLLING HALF HEIGHT DRAWERS 9 & 10. COMPONENT REPLACED AND TESTED PRIOR TO CONFIGURING IT IN THE APPLICATION. THE FSE TESTED IN MEDBANK TOOL AND CUSTOMER PERFORMED CYCLE COUNT/INVENTORY OF THE REPORTED DRAWERS. DURING DCHU VISUAL INSPECTION: P/N 151730-21: WAS RECEIVED WITH 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 INTERNAL COMPONENTS OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: AFTER INVESTIGATION IT IS DETERMINED THAT THE ROOT CAUSE OF THE COMPLAINT COMPONENT WAS GENERATED BY THE DAMAGED PCBA PMC M&M (P/N 151730-01) DUE TO DAMAGED COMPONENT U501 WITH SIGNS OF THERMAL DAMAGE CAUSED BY AN ELECTRICAL FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE DRAWERS 10 AND 09 FAILED TO OPEN. 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
    417778 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown