BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23449093 · Received November 3, 2025

    Report

    Report Number
    2016493-2025-129081
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 23, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE WAS NOT CONFIRMED SINCE THE DEVICE WAS NOT EVALUATED AND REPAIRED BY BD. PER 803.52(F)(11)(III). THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "NOT WORKING." REPORTED PROBLEM CAUSE DESCRIPTION: "SIO BOARD." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "CHECKED THE UNIT AND FOUND THAT, PCU SIO BOARD WAS NOT WORKING. NEED TO REPLACE PCU SIO BOARD." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067381 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown