BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25065648 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25506
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    January 2, 2025
    Report Date
    April 29, 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

    A REVIEW OF THE COMPLAINT HISTORY FOR S/N (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 15OCT2020, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER-REPORTED ISSUE. THE REPORTED CONDITION OF "DEVICES NOT DETECTED ON BUS" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING AND INSPECTION PROCESS. ACCORDING TO WORK ORDER # (B)(4), THE FSE REPORTED THAT REPLACED PMC AND HH CONTROLLER. THE FSE TESTED DEVICE ON BUS, OPEN AND CLOSE DRAWER WITH NO ISSUES. THE USER TESTED SUCCESSFULLY. DURING DCHU VISUAL INSPECTION: P/N 151622-01: THE USE 331392-01 PCBA DWR CNTLR VL.LO/VL WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE FLUID INGRESS, MISSING COMPONENTS, OR PHYSICAL DAMAGE. P/N 151903-01: PCBA PMC FH WAS RECEIVED WITH ONE COMPONENT (U300) WITH THERMAL DAMAGE. DURING DCHU TESTING: P/N 151622-01: USING A DMM ON THE PCBA DRAWER CONTROLLER. NO ANOMALIES WERE FOUND ON THE PCBA, AS ALL COMPONENTS MET THEIR SPECIFIED REQUIREMENTS DURING TESTING. THE HARDWARE TEST APPLICATION (HTA) CONFIRMED THAT THE PCBA DRAWER CONTROLLER WAS FUNCTIONING AS INTENDED. P/N 151903-01: NO FURTHER LABORATORY TESTING WAS REQUIRED FOR THE PCBA FH CUBIE PMC DUE TO THE THERMAL DAMAGE OBSERVED IN THE EXTERNAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER WAS NOT DETECTED ON BUS, WHICH LOCATED ON 12LN AUX1. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT U300 OF FULL HEIGHT CUBIE PMC (P/N: 151903-01) CIRCUIT BOARD. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413006 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown