BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FLUID WARMER IV SET

    MDR report key: 23052849 · Received September 15, 2025

    Report

    Report Number
    3012307300-2025-10615
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    March 11, 2025
    Report Date
    September 15, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    KZL
    UDI-DI
    20695085410017
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT 6061799 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING, DURING RED BLOOD CELL INFUSION, THE INFUSION WAS TOO SLOW. REPORTER STATED THAT THE FIRST UNIT OF RED BLOOD CELL INFUSED APPROPRIATELY, AND DURING INFUSION OF THE SECOND SET, TROUBLESHOOTING FOUND DIFFICULTY WITH THE HEAT EXCHANGE UNIT SLIDE DOWN ON STEP 2 OF SET UP. REPORTER STATED THAT AIR WAS ALSO NOTED IN THE Y PORT OF THE BETWEEN COLLECTION DRIP CHAMBERS, POTENTIALLY IMPEDING FLOW. REPORTER STATED THAT TWO ADDITIONAL UNITS OF PACKED RED BLOOD CELLS WERE GIVEN AND THEN THE RATE SLOWED, AND THAT THEY NOTED A PROBLEM WITH THE TUBING SPIKE LENGTH KINKING IN THE PRESSURE CHAMBER. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398294 LEVEL 1 FLUID WARMER IV SET DEVICE, WARMING, BLOOD AND PLASMA KZL SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061799 20695085410017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown