BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23707878 · Received December 3, 2025

    Report

    Report Number
    2016493-2025-140365
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 11, 2025
    Report Date
    April 11, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE. PART ANALYSIS: THE REPORTED ISSUE ALL DRAWERS SHOW NOT CONNECTED ON BUS ON DEVICE 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 LOOSED 1.2 ROW BOARD CONNECTOR CAUSED DAMAGE TO ITS CONTROLLER AND DRAWER CONTROLLER. THE FSE REPLACED PCBA¿S AND SEATED ALL CONNECTIONS. CONFIGURED STORY SPACE. ESCORT TESTED DRAWERS. PASSED TEST UTILITY TESTS, ATTACHED. DURING DCHU VISUAL INSPECTION: P/N 151622-01: THE PART RECEIVED EXHIBITED THERMAL DAMAGE MARKS ON COMPONENTS C502, R501, R503, AND C605. P/N 151630-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS. DURING DCHU TESTING: P/N 151622-01: FURTHER TESTING WAS NOT NECESSARY DUE TO THERMAL DAMAGE MARKS WERE FOUND DURING VISUAL INSPECTION ON COMPONENTS C502, R501, R503, AND C605. P/N 151630-01: A CALIBRATED DCHU LAB DIGITAL WAS USED TO ASSESS THE CONDITION OF THE PMC USING THE CONTINUITY FUNCTION. THE COMPONENT F201 DID NOT HAVE CONTINUITY. DUE TO THE OPEN CIRCUIT, THE PMC IS CONSIDERED FAULTY AND HTA TESTING WAS NOT NECESSARY. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: AFTER INVESTIGATION IT IS DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS GENERATED BY THE DAMAGED ¿PCBA DWR CNTLR V1.10/V1, P/N 151622-01¿ DUE TO THERMAL DAMAGE IN COMPONENTS C502, R501, R503, AND C605 CAUSED BY AN OVERCURRENT CONDITION; AS WELL AS BY A FAULTY ¿PCBA PMC V1.06/V0.09BL HH¿ DUE TO AN OPEN FUSE (F201).

    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, 13-APR-2015 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 ALL DRAWERS WERE SHOWING AS NOT CONNECTED ON THE BUS. THE FIELD SERVICE ENGINEER (FSE) FOUND A LOOSE 1.2 ROW BOARD CONNECTOR CAUSED DAMAGE TO ITS CONTROLLER AND THE DRAWER CONTROLLER. THE PRINTED CIRCUIT BOARD (PCBA) BOARDS WERE REPLACED, AND ALL CONNECTIONS WERE PROPERLY SEATED. THE STORAGE SPACE WAS CONFIGURED, AND DRAWER FUNCTIONALITY WAS TESTED. ESCORT TESTING CONFIRMED PROPER OPERATION, AND ALL TESTS PASSED SUCCESSFULLY IN THE TEST UTILITY. 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 THE DRAWER WAS NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE MARKS ON COMPONENTS C502, R501, R503 AND C605 AND THE COMPONENT F201 DID NOT SHOW CONTINUITY. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. 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 THE DRAWER WAS NOT DETECTED ON BUS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2856148 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown