BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 23239181 · Received October 7, 2025

    Report

    Report Number
    1416980-2025-04960
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Report Date
    November 6, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K211122
    Removal / Correction Number
    3005700264-06/27/25-004-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6, AND H11: H11: THE DEVICE WAS RECEIVED FOR EVALUATION. AN EVENT HISTORY LOG REVIEW WAS PERFORMED, AND TWO DOWNSTREAM OCCLUSION ALARMS WERE IDENTIFIED DURING THIS INFUSION. NO USO OR AIR IN LINE ALARMS WERE IDENTIFIED. STANDBY MODE WAS NOT IDENTIFIED ON THE EVENT DATE. MOTOR STALL WAS NOT IDENTIFIED IN THE LOGS. NO SECONDARY INFUSION WAS PROGRAMMED IN ASSOCIATION WITH THE REPORT. THE DISPOSABLE WAS LOADED PRIOR TO THE INFUSION AND DOES NOT APPEAR TO BE IN THE CHANNEL FOR GREATER THAN 96 HRS. THE DEVICE WAS NOT SHUTDOWN WITH TUBING LOADED ON THE PREVIOUS INFUSION. A FLOW ACCURACY TEST WAS PERFORMED, AND THE RESULTS PASSED. THE REPORTED CONDITION WAS NOT VERIFIED. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS IN THE PAS 12 MONTHS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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 LARGE VOLUME PUMP UNDERINFUSED DURING INFUSION. THE EXPECTED INFUSION TIME WAS 1 HOUR 30 MINUTES, BUT THE ACTUAL INFUSION TIME WAS 3 HOURS. THE PROGRAMMED VOLUME TO BE INFUSED WAS 25 ML. THE PROGRAMMED RATE/DOSE WAS 100 CC/H. THE FLOW RATE WAS INCREASED TO 200 CC/H, BUT THERE WAS STILL VOLUME LEFT IN THE BAG. THE DEVICE CONTAINED THROMBA. A TRANSFUSION TUBING WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2709857 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40700BAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown THROMBA| TRANSFUSION TUBING