BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23691792 · Received December 2, 2025

    Report

    Report Number
    2016493-2025-139924
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 16, 2026
    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 IMDRF ANNEX CODES. PART ANALYSIS: THE REPORTED ISSUE DRAWER 6 WILL NOT OPEN WAS CONFIRMED DURING FSE 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 AUXILIARY 2 DRAWER FH6 WAS NOT DETECTED ON BUS. THE FSE REPLACED PMC, HH DRAWER CONTROL PCBA AND RETRACTOR BAND. REASSIGNED DRAWER'S POSITIONS AND HTA TEST PASSED. DURING DCHU VISUAL INSPECTION P/N 151903-01. A DETAILED EXAMINATION UNDER A MICROSCOPE WAS PERFORMED TO VISUALIZE THAT THE PART RECEIVED PRESENTED A BROKEN COMPONENT L301. P/N 151622-01. THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS. P/N 353844-01. A DETAILED EXAMINATION UNDER A MICROSCOPE WAS PERFORMED TO VISUALIZE THAT THE PART RECEIVED SHOWED SIGNS OF THERMAL DAMAGE. DURING DCHU TESTING P/N 151903-01: NO FURTHER TEST WAS REQUIRED ON THE PCBA FH CUBIE PMC DUE TO THE VISIBLE PHYSICAL DAMAGE OBSERVED IN THE EXTERNAL INSPECTION P/N 151622-01: A CALIBRATED DCHU LAB DIGITAL MULTIMETER WAS USED TO ASSESS THE CONDITION OF THE DRAWER CONTROLLER BOARD. IT WAS TESTED THE RESISTANCE ACROSS TP501 AND TP503; TP505 AND TP502; MOSFET TEST POINTS. THE RESULT WAS AS EXPECTED. IT WAS PROCEEDED TO PERFORM THE HTA, AND IT PASSED SUCCESSFULLY THE HTA TESTING. P/N 353844-01: NO FURTHER TESTING WAS REQUIRED DUE TO VISIBLE THERMAL DAMAGE FOUND DURING THE VISUAL 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 DRAWER 6 WILL NOT OPEN WAS IDENTIFIED AS A FAULTY PCBA FH CUBIE PMC, P/N 151903-01 DUE TO A BROKEN COMPONENT (L301); A FAULTY ASSY RETRACTOR DWR HH CUBIE, P/N 353844-01 DUE TO THERMAL DAMAGE ALONG THE CABLE.

    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, 04-JAN-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 IN THIS INCIDENT. IT WAS DETERMINED THAT THE AUXILIARY DRAWER WAS NOT DETECTED ON BUS. A FIELD SERVICE ENGINEER (FSE) REPLACED PYXIS MODULE CONTROLLER, HALF HEIGHT DRAWER CONTROL PRINTED CIRCUIT BOARD ASSEMBLY AND RETRACTOR BAND. FSE REASSIGNED DRAWER¿S POSITIONS AND DONE A HARDWARE TEST APPLICATION SUCCESSFULLY WITHOUT ANY ISSUE. 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 AUXILIARY, THE DRAWER WOULDN¿T OPEN. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE ASSY RETRACTOR DWR HH CUBIE. 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 AUXILIARY, THE DRAWER WOULDN¿T OPEN. 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
    365636 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown