BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 23648507 · Received November 25, 2025

    Report

    Report Number
    1416980-2025-05847
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 30, 2025
    Report Date
    March 30, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477183
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: F10/H6: MEDICAL DEVICE PROBLEM CODES (UPDATE A050301 TO A050401). ADDITIONAL INFORMATION: H4, H6 (UPDATE CODES), H11. H4: THE LOT WAS MANUFACTURED AUGUST 12-13, 2025. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR WAS ENTERING AN EXACTAMIX 2400 VALVE SET THROUGH PORT #5. THIS ISSUE WAS DESCRIBED AS, ¿A LEAKY PORT #5 THAT CAUSES AIR IN LINE AND BUBBLES¿. THE LEAK WAS DISCOVERED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945875 EXACTAMIX SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION H938724 60669276 00085412477183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown