BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23691093 · Received December 2, 2025

    Report

    Report Number
    2016493-2025-139814
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 5, 2025
    Report Date
    June 1, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST
    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(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, 30-MAR-2021 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 MAIN DRAWER FAILED. A FIELD SERVICE ENGINEER REPLACED MODULE BOARD AND DRAWER BOARD, REASSIGNED DRAWER, AND CONFIRMED FUNCTIONALITY TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER. PART ANALYSIS: THE REPORTED ISSUE OF THE ¿DRAWER 5 OFF THE BUS¿ WAS CONFIRMED DURING FSE (FIELD SERVICE ENGINEER) TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO THE WORK ORDER (WO) (B)(4), THE FSE FOUND THAT THE CUSTOMER WAS EXPERIENCING AN ISSUE WITH THE FULL HEIGHT OF THE BUS. THE FSE REPLACED BOTH THE PYXIBUS MODULE CONTROLLER BOARD AND THE DRAWER BOARD, AS THE LIGHTS ON THE BACK OF THE MODULE BOARD WERE NOT ON. FSE PERFORMED PROACTIVE SERVICE. DURING DCHU VISUAL INSPECTION: P/N 151622-01: NO DAMAGE WAS OBSERVED. P/N 151903-01: SHOWS SIGNS OF FLUID INGRESS. DURING DCHU TESTING: P/N 151622-01: LABORATORY TESTING WAS CARRIED OUT WITH A DIGITAL MULTIMETER AND NO FAILURES WERE OBSERVED. HTA PERFORMED AND PASSED ALL THE TESTS SUCCESSFULLY. P/N 151903-01: LABORATORY TESTING WAS NOT REQUIRED SINCE THE FLUID INGRESS WAS CONFIRMED. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D) ROOT CAUSE: THE ROOT CAUSE TO THE REPORTED FAILURE DRAWER 5 OFF THE BUS IS ATTRIBUTED TO THE FLUID INGRESS OF THE PART PN 151903-01 WHICH PRODUCES A SHORT IN THE DEVICE, CAUSING THE DRAWER NOT TO BE DETECTED ON THE BUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, HAD DRAWER FAILURE AND NONE OF LIGHT UP BURNED OUT ON THE BOARD. 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, HAD DRAWER FAILURE AND NONE OF LIGHT UP BURNED OUT ON THE BOARD. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE WAS CAUSED BY FLUID INGRESS ON P/N 151903-01, RESULTING IN A SHORT CIRCUIT AND LOSS OF DRAWER DETECTION ON THE BUS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912123 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown