BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25013024 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24230
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    November 7, 2025
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    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, 07-JUN-2023 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 DRAWER IS NOT OPENING WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER: (B)(4), THE FSE REPORTED THAT REPLACED DRAWER CONTROL BOARD AND RETRACTOR BAND ON MAIN FH DRAWER 6. DCHU VISUAL INSPECTION: P/N: 353844-01. A DETAILED EXAMINATION UNDER A MICROSCOPE WAS PERFORMED TO VISUALIZE THE BLACK MARKS OF THE PART RECEIVED, WHICH INDICATES THERMAL DAMAGE. P/N: 151622-01. THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS DCHU LABORATORY TESTING: P/N: 353844-01NO FURTHER TEST WAS REQUIRED DUE TO THERMAL DAMAGE OBSERVED IN THE VISUAL INSPECTION. P/N: 151622-01: PASSED SUCCESSFULLY THE DMM AND HTA TESTING. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT DRAWER IS NOT OPENING WAS A CROSSED CONTINUITY BETWEEN ADJACENT COPPER STRANDS IN THE ASSY RETRACTOR DWR HH CUBIE (P/N: 353844-01), WHICH LED TO THERMAL DAMAGE NOT ASSOCIATED WITH ANY SPECIFIC COMPONENT AND ULTIMATELY COMPROMISED THE DRAWER'S FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWER FAILED TO OPEN. THE CUSTOMER ATTEMPTED TO RECOVER STORAGE SPACE AND REBOOTED THE STATION AS TROUBLESHOOTING STEP, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE ASSY RETRACTOR DRAWER HALF HEIGHT CUBIE. 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
    216726 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown