BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25080930 · Received May 5, 2026

    Report

    Report Number
    2016493-2026-26029
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    December 29, 2025
    Report Date
    April 20, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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-JUL-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 CONDITION OF DRAWER FAILURE AND NOT DETECTED ON BUS WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER WO: (B)(4) THE FSE REPORTED THAT THE LIGHTS ON THE MODULE CONTROLLER WERE NOT ON. THE FSE REPLACED THE CONTROL BOARD AND TESTED IN HARDWARE TEST APPLICATION (HTA). CUSTOMER TESTED. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N: 151903-01: THE INSPECTION REVEALED SIGNS OF THERMAL DAMAGE ON COMPONENT U300 AND CAPACITOR C302. DURING DCHU TESTING: P/N: 151903-01: NO TESTS WERE PERFORMED BECAUSE, ACCORDING TO PAP, WHEN THERMAL DAMAGE IS OBSERVED, NO FURTHER INVESTIGATION IS REQUIRED. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: AFTER INVESTIGATION, THE ROOT CAUSE OF THE DRAWER FAILURE AND NOT DETECTED ON BUS COMPLAINT WAS ATTRIBUTED TO THE PHYSICAL DAMAGE OBSERVED ON THE RETURNED PCBA FH CUBIE PMC (P/N: 151903-01). VISUAL INSPECTION IDENTIFIED THERMAL DAMAGE ON COMPONENT U300 AND CAPACITOR C302 WHICH IS CONSISTENT WITH THE REPORTED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 AND CAPACITOR C302 AND PHYSICAL DAMAGE OBSERVED ON THE RETURNED PCBA FH CUBIE PMC. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166961 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown