BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25125540 · Received May 8, 2026

    Report

    Report Number
    2016493-2026-27270
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    November 11, 2025
    Report Date
    May 6, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    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, 26-JAN-2017 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 NOT DETECTED ON BUS WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FSE ACCORDING TO WORK ORDER WO: (B)(4), THE FSE REPORTED THAT DRAWER WOULDN'T OPEN ON A FH LEGACY AND IT REPLACED DRAWER CONTROLLER BOARD AND PYXIBUS MODULE CONTROLLER BOARD. A POWER PRONG WAS SNAPPED IN HALF. THE FSE RETURNED AND REPLACED THE POWER SUPPLY. DCHU VISUAL INSPECTION: P/N: 151903-01: THE PCBA FH CUBIE PMC WAS INSPECTED USING A CALIBRATED MICROSCOPE, THE PART RECEIVED PRESENTED COMPONENTS (U300 AND C302) WITH BLACK MARKS, WHICH INDICATES THERMAL DAMAGE. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS. DCHU LABORATORY TESTING: P/N: 151903-01: THE PCBA FH CUBIE PMC FURTHER TESTING WAS NOT REQUIRED DUE TO THE VISIBLE THERMAL DAMAGE OBSERVED DURING THE EXTERNAL INSPECTION. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 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: AFTER INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE DRAWER NOT DETECTED ON BUS REPORTED WAS ATTRIBUTED TO A DEFECTIVE PCBA FH CUBIE PMC FOUND WITH THERMAL DAMAGE LOCALIZED IN COMPONENTS U300 AND C302, WHICH IS CONSISTENT WITH THE REPORTED DRAWER NOT DETECTED ON BUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWER NOT DETECTED ON BUS. 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 PCBA FH CUBIE PMC COMPONENTS U300 AND C302. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310470 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown