BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 25017453 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24462
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    November 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
    MD, 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, 21-JUL-2020 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 REPORT CONDITION OF DRAWER NOT OPENING WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER # (B)(4), THE FSE FOUND DRAWERS 5 AND 6 NOT WORKING, AND CORRECTED THE ISSUE BY REPLACING DRAWER CONTROL CIRCUIT BOARD. THE REPAIR WAS TESTED IN HARDWARE TEST APPLICATION. DURING DCHU VISUAL INSPECTION: P/N 151730-21: SIGNS OF THERMAL DAMAGE ON COMPONENT U501 WERE OBSERVED. DURING DCHU TESTING: P/N 151730-21: NO FURTHER LABORATORY TESTS WERE REQUIRED FOR THE PCBA PMC PYXIS MINI FW1-12 DUE TO THE VISIBLE DAMAGE OBSERVED IN THE EXTERNAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE DRAWER NOT OPENING ISSUE WAS IDENTIFIED AS A MALFUNCTION OF THE PCBA PMC PYXIS MINI FW1-12, DUE TO THE THERMAL DAMAGE ON THE COMPONENT U501 RESULTING FROM AN ELECTRICAL FAILURE.

    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
    140907 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown