BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25030139 · Received April 29, 2026

    Report

    Report Number
    2016493-2026-24501
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 20, 2025
    Report Date
    April 27, 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

    E.1 INITIAL REPORTER FACILITY: (B)(6). A REVIEW OF THE COMPLAINT HISTORY FOR S/N (B)(6) WAS PERFORMED IN SALESFORCE IN WHICH IT HAS BEEN IDENTIFIED THAT A COMPLAINT WITH THE SAME FAILURE MODE WAS REPORTED FOR THIS SERIAL NUMBER. 1. CASE (B)(4) /WO (B)(4) - FAILED MAIN DRAWER #1 NOT DETECTED ON BUS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 17FEB2022, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOM ER-REPORTED ISSUE. THE REPORT CONDITION OF "OBGYN PYXIS MAIN DRAWER 1" WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED DURING THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER WO: (B)(4), THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT MATRIX DRAWER NUMBER ONE WAS NOT DETECTED ON BUS. THE FSE INSPECTED THE MACHINE, REPLACED MATRIX CONTROLLER BOARD, AND CONFIGURED IT. CUSTOMER TESTED STATION SATISFACTORY. THE REPORT WAS CLOSED. DURING DCHU VISUAL INSPECTION: P/N 120547-01: HAD A CUT WITH EXPOSED COPPER STRANDS AND SUFFERED THERMAL DAMAGE. P/N 121985-01: HAD BENT COMPONENTS (CAPACITOR C5, MOSFET QI AND SOME JUMPER PINS) INDICATING PHYSICAL DAMAGE. DURING DCHU TESTING: P/N 120547-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE EXPOSED COPPER STRANDS AND BLACK MARKS IN THE CABLE. P/N 121985-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO PHYSICAL DAMAGE TO COMPONENTS. 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 WAS NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA CONTROLLER BIN &FH PYXIBUS IN WHICH THE ASSY CABLE PYXIBUS 6 DRAWER SHOWED EVIDENCE OF DAMAGE AND EXPOSED COPPER STRANDS. 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
    184846 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown