BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 21928502 · Received April 29, 2025

    Report

    Report Number
    1416980-2025-02556
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    March 21, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765851797
    PMA / PMN Number
    K211122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: UPON FURTHER INFORMATION, A SYSTEM ERROR (SE) 21515 (USO SENSOR FAILURE LOW) AND MULTIPLE DOWNSTREAM OCCLUSION ALARMS WERE OBSERVED. THE PUMP WAS PROGRAMMED TO INFUSE 95ML OF FENTANYL AT THE RATE OF 10ML/HR. H11: A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, SE 21515 OCCURS WHEN THE SENSING SYSTEM IS IMPAIRED AND THE ERROR IS DESIGNED TO GIVE THE USER A WARNING THAT THE PUMP MIGHT NOT BE ABLE TO DETECT AN UPSTREAM OCCLUSION. THIS IS A NON-HALTING ERROR AND WILL NOT STOP AN INFUSION. THE OCCURRENCE OF THIS SYSTEM ERROR DOES NOT MEAN THAT AN UNDETECTED OCCLUSION IS PRESENT AT THE TIME OF THE ALARM. WHEN THIS ALARM CONDITION OCCURS, THE USER MAY DECIDE TO STOP AN INFUSION AND OBTAIN A NEW PUMP. THIS SE IS UNLIKELY TO RESULT IN A DEATH OR SERIOUS INJURY. 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 DISPLAYED SYSTEM ERROR DURING PATIENT INFUSION IN THE TRAUMA INTENSIVE CARE UNIT. 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
    1595456 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40700BAXUS N/A 05413765851797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FENTANYL