BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUM IQ

    MDR report key: 21140888 · Received January 13, 2025

    Report

    Report Number
    1314492-2024-04117
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    05413765852428
    PMA / PMN Number
    K211125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION TO G4: PMA/510K # OR BLA #: UPDATE ENTRY TO K211125. ADDITIONAL INFORMATION WAS ADDED TO D4, H6 AND H11. D4: UNIQUE IDENTIFIER (UDI) #: THE SERIAL NUMBER (21) IS UNKNOWN, THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). H11: THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; 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 UNDERINFUSED DURING INFUSION. THE DEVICE INDICATED THAT THE PUMP HAD COMPLETED INFUSION; HOWEVER, IT WAS OBSERVED THAT FLUID REMAINED THAT HAD NOT BEEN DELIVERED TO THE PATIENT. THE DEVICE CONTAINED AMPICILLIN. 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
    1898310 NOVUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 40800BAXUS NA 05413765852428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMPICILLIN.