BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 24835300 · Received April 9, 2026

    Report

    Report Number
    1416980-2026-01253
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765852428
    PMA / PMN Number
    K242390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE IDENTIFIER (UDI) #: THE SERIAL NUMBER (21) IS UNKNOWN, THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP HAD A BLACK SCREEN FOUND DURING DEVICE POWER UP WHILE INITIATING NOVUM SYRINGE SOFTWARE UPDATE (V2.1.4) FROM OVER-THE-AIR (ON-RESTART) DISTRIBUTION FROM IQE. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889067 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40800BAXUS NI 05413765852428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown