BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOTLINE FLUID WARMING DEVICE SET

    MDR report key: 426962 · Received November 7, 2002

    Report

    Report Number
    426962
    Event Type
    Injury
    Date Received
    November 7, 2002
    Date of Event
    November 5, 2002
    Report Date
    November 6, 2002
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS TIJUANA, MX FOR LEVEL 1, INC.
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOT LINE WARMING DEVICE TUBING FOUND TO HAVE A LEAK CAUSING A BREAK IN STERILE TO NONSTERILE FLUID BARRIER RESULTING IN MIXING OF THE NONSTERILE WARMING FLUID AND THE STERILE FLUIDS THE PT WAS RECEIVING VIA THE INNER TUBE. IVS WERE STARTED IN THE RIGHT ARM (#18) WITH CONTINUOUS FLOW AND EXTENSION TUBING AND IN THE LEFT ARM (#16) WITH Y-TYPE BLOOD TUBING AND HOT LINE SYSTEM CONNECTED. PT WAS SUPINE AND THEIR ARMS WERE POSITIONED OVER THE CHEST WITH A FRAME, FOAM PADDING AND WEBRIL WRAP FROM THE HANDS TO THE MID-HUMERUS AREA. THE LEFT IV (HOT-LINE SYSTEM) BEGAN FLOWING BACKWARDS SO THE RN SQUEEZED THE BULB TO CLEAR THE TUBING. AFTER A TIME, RN NOTICED AGAIN THAT THE TUBING WAS BLOOD TINGED. RN FLUSHED THE EXTENSION PART OF THE LINE WITH 20 CC FLUID, BUT THE HOT LINE TUBING WAS STILL RED TINGED. RN SQUEEZED THE BULB ON THE Y-TYPE TUBING BUT THE HOT-LINE TUBING REMAINED RED TINGED. ABOUT 30 MIN LATER, RN NOTICED THAT THE WATER IN THE HOT LINE UNIT WAS RED TINGED SO RN IMMEDIATELY CLAMPED THE SYSTEM IN TWO PLACES, CALLED FOR HELP TO CHANGE THE LINE AND TO OBTAIN ANOTHER HOTLINE UNIT. STAFF IMMEDIATELY RESPONDED. STAFF DISCONNECTED THE IV TUBING UP TO THE EXTENSION SET (THE IV AND EXTENSION SET WERE WRAPPED INTO THE FRAME SYSTEM). THE HOTLINE WAS REMOVED FROM THE O.R. WITH THE HOTLINE TUBING AND Y-TYPE BLOOD TUBING INTACT. STAFF INFORMED THE TWO SURGEONS IMMEDIATELY. THEY DISCUSSED THE OPTIONS AND DECIDED TO CONTINUE WITH THE PROCEDURE (ALREADY 30 MIN INTO THE PROCEDURE). ANTIBIOTICS (FLAGYL AND GENTAMYCIN) WERE ORDERED IN ADDITION TO THE ANCEF 1 GRAM, WHICH THE PT RECEIVED PRIOR TO INCISION. HOT-LINE TUBING WITH THE SAME LOT NUMBERS WERE REMOVED FROM CENTRAL SUPPLY AND ANESTHESIA STOCK POINTS. CULTURES WERE TAKEN OF THE FLUID IN THE RESERVOIR OF THE HOT-LINE UNIT. WHEN THE PT WAS REPOSITIONED PRONE AND THE HANDS WERE UNWRAPPED, THE EXTENSION SET WAS DISCONNECTED AND REMOVED FROM THE O.R. (TO BE KEPT WITH THE ORIGINAL HOT-LINE SET. CULTURES WERE DRAWN AND SENT TO LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOTLINE FLUID WARMING DEVICE SET * DWJ RESPIRATORY SUPPORT PRODUCTS TIJUANA, MX FOR LEVEL 1, INC. REFL - 70 2002 02BM

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| O| R