BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 TRAUMA FAST FLOW DISPOSABLES

    MDR report key: 21118735 · Received January 9, 2025

    Report

    Report Number
    9617604-2025-00026
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 9, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    KZL
    UDI-DI
    10695085410013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 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. COMPLAINT FOR THE FAILURE MODE "A0103 - CLAMP ISSUE" COULD NOT BE CONFIRMED BY INVESTIGATION AS NO SAMPLES NOR PICTURES WAS PROVIDED BY THE CUSTOMER. 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, LSM WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLAMP HAD MALFUNCTIONED. ONE SIDE HAD CLAMPED, ONE SIDE OPEN TO TRANSFUSE TO PATIENT. BLOOD BACK FLOWED INTO THE BAG WITH THE CLAMP ENABLED RATHER THAN THROUGH TO THE PATIENT. CLAMP WAS DOUBLE CHECKED TO ENSURE IT WAS FULLY ENGAGED, BUT BLOOD CONTINUED TO BACK FLOW. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364645 LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DEVICE, WARMING. BLOOD AND PLASMA KZL SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061799 10695085410013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown