BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25032723 · Received April 29, 2026

    Report

    Report Number
    2016493-2026-24738
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    October 10, 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
    IL, 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, 07-OCT-2024 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 CONDITION OF DRAWERS 05 AND 06 NOT OPENING WAS CONFIRMED BY FSE AND VERIFICATION OF THERMAL DAMAGE WAS SUBSEQUENTLY CONFIRMED DURING THE DCHU INVESTIGATION PROCESS. ACCORDING TO WORK ORDER #(B)(4) THE FSE REPORTED THAT CONTROLLER BOARD FOR DRAWERS 5 AND 6 HAD NO LIGHTS. THE FSE REPLACED MODULE CONTROLLER. THE FSE INSPECTED FULL HEIGHT MATRIX DRAWER 11 AND FOUND NO LIGHTS ON THE MODULE CONTROLLER. THE FSE REPLACED MODULE CONTROLLER AND MEDBANK SUPPORT ASSISTED WITH CONFIGURING DRAWER AND NO OTHER ISSUES WERE OBSERVED. DURING DCHU VISUAL INSPECTION: P/N 151730-21: THE PCBA RECEIVED PRESENTED THERMAL DAMAGE MARKS ON COMPONENT U501 WHICH WAS RUPTURED DUE TO THE OVERCURRENT CONDITION. DURING DCHU TESTING: P/N 151730-21: NO DCHU TESTING WAS NECESSARY DUE TO THE OBSERVED THERMALLY DAMAGED COMPONENT U501. 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 DRAWER 05 AND 06 NOT OPENING WAS DETERMINED TO BE DUE TO A THERMALLY DAMAGED COMPONENT U501 ON THE PCBA PMC PYXIS MINI FW1-12 (P/N 151730-21) CIRCUIT BOARD RESULTING FROM AN OVERCURRENT CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE DRAWERS 05 AND 06 DID NOT OPEN AND APPEARED YELLOW ON THE POPULATE BUTTONS AND DID NOT OPEN WHEN THE LOCATE BUTTON WAS PRESSED. THE CUSTOMER TRIED TO REBOOT THE STATION, BUT THIS DID NOT RESOLVE THE ISSUE. 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
    16726 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown