BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS

    MDR report key: 3912756 · Received June 23, 2014

    Report

    Report Number
    2183502-2014-00428
    Event Type
    Death
    Date Received
    June 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVAL IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE DEVICE WAS IN USE WITH A PT WHO SUFFERED SEVERE BLOOD LOSS. THE USER FACILITY OBSERVED THE TUBING BECAME DISCONNECTED FROM THE CLAMP SLOT AND THE PUMP ALARMED, WARNING THE USER TO CHECK THE TUBING. SEVERAL TUBING SETS FROM THE SAME LOT WERE ATTEMPTED ON MULTIPLE FLUID WARMING DEVICES; NO ATTEMPTS WERE INDICATED TO BE SUCCESSFUL. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364838 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS KZL: BLOOD AND PLASMA WARMING DEVICE KZL SMITHS MEDICAL ASD, INC. NA 2585120

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death INTEGRATED AIR DETECTOR/CLAMP| LEVEL 1 H-1200 FAST FLOW FLUID WARMER WITH,