BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24952856 · Received April 22, 2026

    Report

    Report Number
    2016493-2026-23178
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 17, 2025
    Report Date
    April 22, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR S/N (B)(6) WAS PERFORMED IN SALESFORCE, WHICH DID NOT LOCATE A SIMILAR COMPLAINT WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 21MAY2021, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER-REPORTED ISSUE. THE REPORTED CONDITION OF REPEATED FAILURES AND EJECTING CUBIES WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER 01909459, THE BD FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE HALF HIGH DRAWERS 1.2, 2.2 AND 3.1 HAD MULTIPLE FAILED POCKETS NOT DETECTED ON BUS. FSE INSPECTED MACHINE AND RE-SEATED ROW BOARD CABLES. DRAWER 3.1 STILL HAD FAILURES. REPLACED DRAWER CONTROLLER BOARD. CUSTOMER TESTED STATION SATISFACTORILY. DURING DCHU VISUAL INSPECTION: P/N 151622-01: RECEIVED WITH THERMAL DAMAGE TO RESISTOR R206. DURING DCHU TESTING: P/N 151622-01: BENCH TESTING COULD NOT BE PERFORMED DUE TO THERMAL DAMAGE ON COMPONENTS DETECTED DURING VISUAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES SM2W2 MAIN DRAWER 1.2 (ROW B), MAIN DRAWER 2.2, AND MAIN DRAWER 3.1 REPEATEDLY FAILED ACROSS ALL DRAWER CUBIES. THE CUSTOMER CONFIRMED THAT EJECTING AND REPLACING THE CUBIES DID NOT RESOLVE THE FAILURES. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT COMPONENT R206 ON THE CIRCUIT BOARD EXPERIENCED AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE DRAWER OPEN/CLOSE STATE. HOWEVER, THERE WERE NO DELAYS, ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71931 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown