BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24940425 · Received April 21, 2026

    Report

    Report Number
    2016493-2026-22864
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    October 8, 2025
    Report Date
    April 16, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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, 22-AUG-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 CONDITION OF STATION NOT POWERING UP WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPLACED BOTH PCBS AND THE RETRACTOR BAND TO RESOLVE THE ISSUE OF ALL CUBIES BEING OFFLINE, THEN VERIFIED PROPER OPERATION IN THE APPLICATION. DURING DCHU VISUAL INSPECTION P/N 119879-01: WAS RECEIVED WITH THERMAL DAMAGE ON THE COIL COVER. P/N 151622-01: WAS RECEIVED WITH A DETACHED COMPONENT D601. DURING DCHU TESTING P/N 119879-01: NO FURTHER TESTING WAS REQUIRED DUE TO THERMAL DAMAGE FOUND DURING THE EXTERNAL INSPECTION. P/N 151622-01: NO FURTHER TESTING WAS REQUIRED DUE TO PHYSICAL DAMAGE FOUND DURING 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 COMPLAINT, STATION NOT POWERING UP WAS DETERMINED TO BE: A FAULTY SOLENOID 12 VDC HH DRAWER CUBIE, P/N 119879-01, WHICH EXHIBITED THERMAL DAMAGE IN THE COIL AND CONSEQUENTLY COMPROMISED THE PROPER OPERATION OF THE DRAWER. A FAULTY USE 331392-01 PCBA DWR CNTLR V1.10/V1, P/N 151622-01, DUE TO A DETACHED COMPONENT D601, WHICH PREVENTS A PROPER FUNCTIONALITY OF THE BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES WAS NOT TURNING ON. THE CUSTOMER TRIED TO PLUG INTO DIFFERENT OUTLET, BUT STILL FAILED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE SOLENOID 12 VDC HH DRAWER 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
    573260 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown