BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE FLUID WARMING SET

    MDR report key: 5067766 · Received September 10, 2015

    Report

    Report Number
    2183502-2015-00657
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC., ROCKLAND, MA
    Product Code
    LGZ
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    FOUR UNUSED SAMPLES RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE RETURN CONNECTOR AND REFLEX CONNECTOR WERE PROPERLY INSERTED INTO THE 3 LUMEN TUBE OF ALL SAMPLES, NO DAMAGE FOUND IN THE TRIPLE LUMEN, NO ROLL-OVER TUBE ON BONDINGS, NO GAPS OR INCOMPLETE BONDINGS WERE FOUND BETWEEN THE CONNECTORS AND THE TRIBLE LUMEN TUBE. SAMPLES WERE THEN CONNECTED TO THE HL-90 HOTLINE FLUID WARMER UNIT TO IDENTIFY ANY BREACH LOCATED IN THE ASSEMBLY. THERE WAS NO BREACH FOUND IN THE L-70 ASSEMBLY IN ANY OF THE FOUR SAMPLES RECEIVED. ALL SAMPLES PASSED FUNCTIONALITY TESTING AND NO MIXED LIQUIDS WERE FOUND. UNABLE TO REPLICATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A FLUID WARMER FOR WARMING OF BLOOD, THE RESERVOIR FILLED BACK UP WITH BLOOD. THE END USER REPORTED THEY FOUND A SLIT IN THE DISPOSABLE SET. NO ADVERSE HEALTH OUTCOME OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600620 LEVEL 1 HOTLINE FLUID WARMING SET WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC., ROCKLAND, MA NA 2941833

    Patients

    Seq Age Sex Outcome Treatment
    1