BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23727090 · Received December 5, 2025

    Report

    Report Number
    2016493-2025-140940
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 17, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: THE REPORTED CONDITION OF HARDWARE FAILURE - AUX DRAW 6 WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER #(B)(4) THE FSE REPORTED THAT UPON DIAGNOSING DRAWER BOARD WAS REPLACED. CUSTOMER CONFIRMED STATION WAS FUNCTIONING PROPERLY. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N 151622-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE ON RESISTOR R503 AND CAPACITORS C502 AND C513. DURING DCHU TESTING: P/N 151622-01: THE TESTING FROM DCHU WAS NOT NECESSARY DUE TO THE SIGNS OF THERMAL ON THE INTERNAL COMPONENTS OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO RESISTOR R503 AND CAPACITORS C502 AND C513 ON THE DRAWER CONTROLLER BOARD (P/N 151622-01) RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.

    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, 11-MAR-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER 6 HARDWARE FAILED. A FIELD SERVICE ENGINEER REPLACED DRAWER CONTROLLER BOARD AND CONFIRMED FROM THE CUSTOMER THAT THE STATION WAS FUNCTIONING PROPERLY TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER HAD HARDWARE FAILURE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA DWR CNTLR BOARD. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER HAD HARDWARE FAILURE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493221 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown