BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25062644 · Received May 3, 2026

    Report

    Report Number
    2016493-2026-25379
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    December 31, 2024
    Report Date
    April 27, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A 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 08FEB2019, 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 "DRAWER 5 NOT SENSING CLOSED" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING AND INSPECTION PROCESS. ACCORDING TO WORK ORDER #(B)(4) THE FSE REPORTED THAT THE FULL HEIGHT (FH) CUBIE DRAWER 5 WAS NOT SENSING WHEN BEING CLOSED. FSE INSPECTED FOR MISSING MAGNETIC, BUT IT WAS INTACT. FSE THEN REPLACED THE LATCH SENSOR, BUT THE ISSUE PERSISTED. FINALLY, THE FSE REPLACED THE FH PYXIBUS INTERFACE PCB. AFTER THE REPLACEMENT, THE DRAWER BECAME FUNCTIONAL, AND THE CUSTOMER WAS ABLE TO SUCCESSFULLY ACCESS THE DRAWER. DURING DCHU VISUAL INSPECTION: P/N 151903-01: RECEIVED WITH THERMAL DAMAGE PRESENT ON COMPONENT U300. P/N 353949-01: RECEIVED WITH NO SIGNS OF PHYSICAL DAMAGE, MISSING COMPONENTS OR SIGNS OF FLUID INGRESS. DURING DCHU TESTING: P/N 151903-01: SINCE THERMAL DAMAGE IS PRESENT ON THE COMPONENT, NO TESTING IS REQUIRED. P/N 353949-01: SINCE THE COMPONENT MEASURED DURING DMM TESTING DID NOT MEET EXPECTED VALUE, FUNCTIONAL TESTING WAS DEEMED UNNECESSARY. 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, THE DRAWER FAILED TO RECOGNIZE AS CLOSED. 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 DELAY, NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324979 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown