BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 22206850 · Received June 13, 2025

    Report

    Report Number
    1416980-2025-03360
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765852428
    PMA / PMN Number
    K242390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST
    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: H6 AND H11: THERE WERE NO FINDINGS IN THE HISTORY LOG THAT WOULD INDICATE WHY THE TOTAL VOLUME (WITHIN IQE LOGS) WOULD DECREASE BY 0.3952ML OVER THE DURATION THE PUMP WAS NOT INFUSING. THE LOGS SHOW THAT THE USER CLEARED THE ML GIVEN PRIOR TO BEGINNING THE INFUSION. 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. 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 UNDER-INFUSED. THIS WAS OBSERVED DURING PATIENT INFUSION WITH ACYCLOVIR (7 MG/ML) ADMINISTERED THROUGH A NON-BAXTER 20 ML SYRINGE AT 10 ML/HR. 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
    816365 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40800BAXUS NA 05413765852428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ACYCLOVIR.| MONOJECT SYRINGE.