BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER LVP NOVUM PUMP

    MDR report key: 21560303 · Received March 10, 2025

    Report

    Report Number
    MW5167448
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 4, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NEW HEPARIN BAG HUNG (B)(6) 2025 1721 AT 35.8 ML/HR. HEPARIN RATE CHANGE 03/03 2037 TO 33.7 ML/HR. HEPARIN BAG (25,000 UNITS IN 500 ML) EMPTY 03/03 2258. STAT PTT >200, ANTI-XA >2.0. NO BLEEDING NOTED, HEPARIN HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339627 BAXTER LVP NOVUM PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEPARIN