BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25014546 · Received April 28, 2026

    Report

    Report Number
    2016493-2026-24355
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    October 24, 2025
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 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, 05-MAY-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. PART ANALYSIS: THE REPORTED ISSUE MAIN DRAWER 5 WILL NOT RECOGNIZE THE DRAWER IS CLOSED AND REQUIRES MAINTENANCE 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 02168965, THE FSE REPORTED THAT VERIFIED ISSUE IN HTA, POWERED OFF STATION. REPLACED OPEN/CLOSE SENSOR IN CLOSE LATCH BLOCK. POWERED ON AND TESTED IN HTA. DURING DCHU VISUAL INSPECTION: P/N 118234-01. THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, LOOSE COMPONENTS, FLUID INGRESS OR MISSING COMPONENTS. 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 118234-01: A DMM WAS USED TO ASSESS THE CONDITION OF THE PART RECEIVED. IT PASSED SUCCESSFULLY THE DMM TESTING. IT WAS PERFORMED HTA TESTING. THE PCBA OPEN/CLOSE SENSOR DRAWER PAS3500 FUNCTIONED AS INTENDED P/N 151622-01: A CALIBRATED DCHU LAB DIGITAL MULTIMETER WAS USED TO ASSESS THE CONDITION OF THE DRAWER CONTROLLER BOARD. THE RESISTANCE MEASURED IN THE MOSFET TP WAS 2.2, WHICH IS OUTSIDE THE ACCEPTABLE RANGE TO BE CONSIDERED AS FUNCTIONAL. DUE TO LOW RESISTANCE MEASURED IN TP MOSFET, HTA TESTING WAS NOT NECESSARY. 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 COMPLAINT OF MAIN DRAWER 5 WILL NOT RECOGNIZE THE DRAWER IS CLOSED AND REQUIRES MAINTENANCE WAS DUE TO: A SHORTED DIODE D501 ON THE DRAWER CONTROLLER BOARD WHICH LED TO CIRCUIT INSTABILITY AND ULTIMATELY COMPROMISED THE DRAWER'S FUNCTIONALITY. DUE TO CROSSED CONTINUITY BETWEEN ADJACENT COPPER STRANDS OF THE ASSY RETRACTOR DWR HH CUBIE (P/N 353844-01) WHICH LED TO OBSERVE THERMAL DAMAGE GENERATED BY AN OVERCURRENT WHICH COMPROMISED THE DRAWER'S FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWER 5 FAILED TO RECOGNIZE AS CLOSED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE ASSY RETRACTOR DWR HH CUBIE. THERE WERE NO DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371343 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown