BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IV PUMP

    MDR report key: 21434766 · Received February 21, 2025

    Report

    Report Number
    MW5166663
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 13, 2025
    Report Date
    February 18, 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

    BAXTER PUMP PROGRAMMED TO INFUSE HEPARIN AT PRESCRIBED RATE; HOWEVER, NO MEDICATION WAS INFUSED INTO PATIENT. NEW BAG WAS HUNG AT BEGINNING OF SHIFT. PUMP SETTINGS AND MEDICATION VERIFIED VIA 2 RN'S. NOON ANTI-XA RESULT WAS MUCH LESS THAN PREVIOUS RESULT. PA NOTIFIED. LAB REDRAWN AND RESULT WAS AGAIN SUBTHERAPEUTIC. PA AND CHARGE RN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414709 NOVUM IV PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEPARIN