BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FLUID WARMER IV SET

    MDR report key: 22507244 · Received July 15, 2025

    Report

    Report Number
    3012307300-2025-08354
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    November 13, 2024
    Report Date
    July 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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00209. THE DATE OF THAT SUBMISSION WAS 15-APR-2025. H6: NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 4170271 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLUID LEAKED IN THE CLAPPED CHAMBER AT THE BOTTOM OF THE PRODUCT¿S INFUSION CONNECTION. PER REPORTER, THE EVENT OCCURRED AT THE HOSPITAL AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128137 LEVEL 1 FLUID WARMER IV SET DEVICE, WARMING, BLOOD AND PLASMA KZL SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4170271 20695085410017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown