BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 24941072 · Received April 21, 2026

    Report

    Report Number
    2016493-2026-22882
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    August 22, 2025
    Report Date
    April 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, 17-MAY-2018 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 CONDITION OF DRAWER NOT DETECTED ON BUS WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED DURING DCHU INVESTIGATION PROCESS. ACCORDING TO WORK ORDER#: (B)(4), THE BD FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT FULL HEIGHT DRAWER 5 WAS NOT DETECTED ON THE SYSTEM BUS. NO LIGHT WAS PRESENT ON THE DRAWER CONTROLLER BOARDS. BOTH DRAWER BOARDS WERE REPLACED, AND FUNCTIONALITY WAS CONFIRMED THROUGH A SUCCESSFUL HARDWARE TEST IN HTA. DURING DCHU VISUAL INSPECTION: P/N: 151903-01: WAS RECEIVED AND CONFIRMED THERMAL DAMAGE ON COMPONENT U300 UPON MICROSCOPE INSPECTION. P/N: 151622-01: WAS RECEIVED WITH NO SIGNS OF PHYSICAL DAMAGE, MISSING COMPONENTS, THERMAL DAMAGE OR FLUID INGRESS. DURING DCHU TESTING: P/N: 151903-01: NO DCHU TESTING WAS REQUIRED DUE TO THE THERMAL DAMAGE OBSERVED ON COMPONENT U300. P/N 151622-01: THE DRAWER CONTROLLER WAS EVALUATED ON AN ESD PROTECTED SURFACE WITH A CALIBRATED DMM AND PASSED THE RESISTANCE TESTING. ALSO, IT WAS MOUNTED TO A KNOWN-GOOD DRAWER FOR THE FUNCTIONAL TESTING (HTA) AND PASSED THE TEST WITH NO ANOMALIES OR INTERMITTENT BEHAVIOR OBSERVED. 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 (CUBIE DRAWER/DEVICE NOT DETECTED ON BUS) WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U300 ON THE FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD RESULTING FROM AN OVERCURRENT CONDITION. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE DRAWER FUNCTIONS AND PREVENTED THE RECOVERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE CUBIE DRAWER 5 NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 OF FULL HEIGHT CUBIE PMC CIRCUIT BOARD. 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
    261457 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown