BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 22524245 · Received July 16, 2025

    Report

    Report Number
    1416980-2025-03775
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765851797
    PMA / PMN Number
    K211122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE: THE EVENT OCCURRED ON AN UNSPECIFIED DATE BETWEEN 06/12//2025 AND 06/13/2025. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: UPON FURTHER REVIEW, THE NOVUM PUMP DID NOT HAVE AIR IN THE LINE; THEREFORE, THE DEVICE IS NO LONGER SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT OF AIR IN LINE - FALSE ALARM.

    Description of Event or Problem · 0

    DURING A TUBING SET EVALUATION, AIR WAS OBSERVED IN THE LINE; HOWEVER, THE NOVUM IQ LARGE VOLUME PUMP DID NOT ALARM FOR THE AIR IN LINE. THE SET WAS UNDERGOING A SHORT, SIMULATED THERAPY OF 50ML/HOUR FOR TWENTY-FOUR HOURS. AT AN UNKNOWN TIME DURING THE SIMULATED THERAPY, AIR WAS NOTED IN THE LINE. THE NOVUM PUMP DID NOT ALARM FOR THE AIR. SINCE THE EVENT OCCURRED DURING EVALUATION, THERE WAS NOT PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553545 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40700BAXUS NA 05413765851797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown