BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21432316 · Received February 21, 2025

    Report

    Report Number
    2016493-2025-62922
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 30, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403519284
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III). THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 600.6825. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. CUSTOMER DID TRANSFER OF THEIR NETWORK CONFIGURATION. ALLEGEDLY DEVICE STILL DID NOT WORK. WHEN CUSTOMER GOES INTO THE OPTIONS THE ANESTHESIA MODE, NETWORK STATUS, WIRELESS CONNECTION AND THE FIPS 140-2 MODE IS GREYED OUT AND DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110497 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403519284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown