BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25109853 · Received May 7, 2026

    Report

    Report Number
    2016493-2026-26700
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    March 3, 2025
    Report Date
    May 5, 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 080CT2020, 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 "MAIN 6 WON'T RECOVER" WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER (B)(4), THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT UPON INSPECTION, MATRIX DRAWER NUMBER SIX FAILED AND WOULD NOT RECOVER IN THE APPLICATION. A LONG REBOOT WAS ATTEMPTED, AND ALL CONNECTIONS WERE RE-SEATED; HOWEVER, THESE ACTIONS DID NOT RESOLVE THE ISSUE. UPON FURTHER INSPECTION, PHYSICAL DAMAGE WAS FOUND ON THE MATRIX CONTROLLER BOARD. THE BOARD WAS REPLACED SUCCESSFULLY ON THE STATION. AFTER RECOVERY, THE CUSTOMER WAS ABLE TO TEST THE MATRIX DRAWER SUCCESSFULLY IN THE HARDWARE TEST APPLICATION (HTA), WITH NO ISSUES OBSERVED. DURING DCHU VISUAL INSPECTION: P/N 121985-01: THE UNIT REVEALED SIGNS OF THERMAL DAMAGE, SPECIFICALLY ON COMPONENT PTCI. NO FLUID INGRESS OR OTHER ANOMALIES WERE OBSERVED. DURING DCHU TESTING: P/N 121985-01: NO FURTHER TESTING WAS REQUIRED DUE TO EVIDENCE OF THERMAL DAMAGE OBSERVED ON COMPONENT PTCI. 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 MAIN DRAWER 6 FAILED TO RECOVER. THE CUSTOMER ATTEMPTED TO REBOOT THE STATION, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COMPONENT PTCI. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481344 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown