BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23714964 · Received December 4, 2025

    Report

    Report Number
    2016493-2025-140631
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 15, 2025
    Report Date
    November 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 CONDITION OF "DRAWER NOT OPENING" WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT REPLACED COM SLED, MODULE AND DRAWER BOARD. THE FSE CONFIGURED AND RAN DIAGNOSTICS SUCCESSFULLY. DURING DCHU VISUAL INSPECTION P/N 151903-01 (SN: (B)(6)): ALL THREE BOARDS RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 151622-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 353844-01: WAS RECEIVED WITH COPPER STRANDS IN CONTACT WITH ADJACENT COPPER STRANDS. P/N 353372-21: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. DURING DCHU TESTING P/N 151903-01 (SN: (B)(6)): PASSED THE DMM AND HTA TESTING. P/N 151622-01: PASSED THE DMM AND HTA TESTING. P/N 353844-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE THERMAL DAMAGE OBSERVED ON COPPER STRANDS DURING THE VISUAL INSPECTION. P/N 353372-21: PASSED THE HTA TESTING THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT OF "DRAWER NOT OPENING" WAS DUE TO CROSSED CONTINUITY BETWEEN ADJACENT COPPER STRANDS OF THE "ASSY RETRACTOR DWR HH CUBIE" (P/N 353844-01) WHICH LED TO THE OBSERVED THERMAL DAMAGE AND ULTIMATELY COMPROMISED THE DRAWER'S FUNCTIONALITY.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY: (B)(6). 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, 31-JAN-2023 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 SYSTEM DRAWER WAS NOT OPENING AND FAILED TO RESPOND. A FIELD SERVICE ENGINEER FOUND THAT THE DRAWER HAD INTERMITTENT FAILURES. FURTHER, THE ENGINEER REPLACED THE COMMUNICATION SLED, PYXIS MODULE CONTROLLER BOARD, AND DRAWER CONTROLLER BOARD, CONFIGURED THEM, AND RAN DIAGNOSTICS TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER WAS NOT OPENING. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE DRAWER NOT OPENING WAS DUE TO CROSSED CONTINUITY IN THE RETRACTOR ASSEMBLY CAUSING THERMAL DAMAGE AND FUNCTIONAL FAILURE THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER WAS NOT OPENING. THE CUSTOMER STATED 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
    2800710 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown