BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23669932 · Received November 28, 2025

    Report

    Report Number
    2016493-2025-138936
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 5, 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
    MO, 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 COMPLAINTS 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, 20-JUL-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 DRAWER 2.1 WAS UNDETECTED ON THE BUS. THE FIELD SERVICE ENGINEER (FSE) ACCESSED STATION TO IDENTIFY THE AFFECTED DRAWER. THE CONTROL BOARD WAS REMOVED AND TESTED, BUT IT FAILED, SO THE CONTROLLER FOR DRAWER 2.1 WAS REPLACED. A HARDWARE ACCEPTANCE TEST WAS THEN PERFORMED AND PASSED SUCCESSFULLY. ADDITIONAL STEPS INCLUDED INSPECTING WIRING AND LATCHES AND RUNNING THE HARDWARE TEST APPLICATION, WHICH CONFIRMED ALL TESTS PASSED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: THE REPORT OF THE MEDES - UNDETECTED DRAWER ON BUS WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FSE ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT LOGGED INTO STATION TO IDENTIFY DRAWER AND REMOVED THE CONTROL BOARD. THE FSE TESTED IT AND IT DID NOT PASS, SO REPLACE THE CONTROLLER FOR DRAWER 2-1. THEN THE FSE RAN THE HARDWARE ACCEPTANCE TEST, AND IT PASSED. DURING DCHU VISUAL INSPECTION P/N 151622-01: WAS RECEIVED WITH COMPONENTS (D501, Q501 AND R501) WITH THERMAL DAMAGE. DURING DCHU TESTING P/N 151622-01: NO FURTHER LABORATORY TESTS WERE REQUIRED DUE TO THE VISIBLE DAMAGE OBSERVED IN 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 REPORTED ISSUE MEDES - UNDETECTED DRAWER ON BUS WAS IDENTIFIED AS A FAULTY USE 331392-01 PCBA DWR CNTLR V1.10/V1 DUE TO THERMAL DAMAGE ON COMPONENTS D501, Q501 AND R501, WHICH COMPROMISES THE PROPER FUNCTIONALITY OF THE WHOLE ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER WAS UNDETECTED ON THE BUS AND WAS UNRECOVERABLE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN 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 WAS UNDETECTED ON THE BUS AND WAS UNRECOVERABLE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA DWR CNTLR COMPONENTS D501, Q501 AND R501. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN 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
    188055 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown