BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER

    MDR report key: 7593055 · Received June 12, 2018

    Report

    Report Number
    3012307300-2018-02320
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    September 25, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    LGZ
    UDI-DI
    50695085820909
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER WAS RECEIVED IN FAIR CONDITION WITH EVIDENCE OF SCUFFING ON THE CASE. THE UNIT WAS MANUFACTURED IN 2017. THE TECHNICIAN TOOK THE FOLLOWING ACTIONS TO TEST THE DEVICE. INSTALLED L-70 TEST DISPOSABLE AND POWERED ON UNIT. TESTED LOW FLUID SWITCH BY PRESSING ACTUATOR DOWN USING PLASTIC TUBE. THE LOW FLUID ALARM DID NOT ACTIVATE. PRESSED GENERAL ALARM TEST SWITCH AND NO VISUAL OR AUDIBLE ALARMS WERE PRESENT. REMOVED FRONT COVER AND INVESTIGATED FURTHER: FOUND CIRCUIT BOARD WAS DAMAGED WITH LEDS CR 302 AND CR303 MISSING FROM CIRCUIT BOARD, AND WHITE STAND OFFS IN BOTTOM OF CASE. THIS TYPE OF DAMAGE WAS DETERMINED TO BE CAUSED BY PUSHING THE TOP COVER IN FORCEFULLY AND NOT CHECKING TO MAKE SURE LEDS ARE PROPERLY POSITIONED WITHIN THE RECESSES OF THE FRONT COVER. IT WAS ALSO NOTED THAT THE LCD DISPLAY WAS INACCURATE, DISPLAYING 42.4 DEGREES INSTEAD OF 41.9 DEGREES. THE GLYPTAL SEAL WAS BROKEN ON POTENTIOMETER INDICATING IT HAD BEEN TURNED AFTER IT WAS ORIGINALLY SET BY MANUFACTURING. IT WAS DETERMINED THAT THE CUSTOMER MAY HAVE BEEN TURNING THIS POTENTIOMETER TO CHECK THE OVER TEMPERATURE ALARM. LASTLY THE MAIN CIRCUIT BOARD PART NUMBER 7012091 WAS FOUND TO BE FAULTY DUE TO CUSTOMER DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER EXPERIENCED NO AUDIO ALARM FOR FLOAT SWITCH AND OVER TEMPERATURE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434947 LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL, ASD, INC. 50695085820909

    Patients

    Seq Age Sex Outcome Treatment
    1