BEUDAMED
    FDA Adverse Event Summary report: N

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 5158915 · Received October 19, 2015

    Report

    Report Number
    1018233-2015-00398
    Date Received
    October 19, 2015
    Report Date
    May 24, 2016
    Manufacturer
    DYMAX CORP. -2523003
    Product Code
    DWJ
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE WAS SAID NOT TO BE REWARMING THE PATIENT. THE CLINICAL REPRESENTATIVE HAD THE USER ADJUST WATER TEMPERATURE LIMITS TO MAXIMUM 42 DEGREES CELSIUS. THE PATIENT HAD EXPIRED DUE TO CARDIAC ARREST AND THE DOCTOR WANTED THE PATIENT REWARMED AS QUICKLY AS POSSIBLE TO BE ABLE TO CLAIM THE PATIENT BRAIN DEAD. THE DEVICE'S CASE DATA IS ATTACHED AND WAS USED TO CONFIRM THE PATIENT WAS NOT RESPONDING TO REWARMING; HOWEVER, THE DEVICE ITSELF WAS PROVEN TO OPERATE CORRECTLY, PER THE CASE DATA. THE CASE DATA SHOWED THE TEMPERATURE HAD INCREASED TO MAXIMUM AND ACHIEVED THE WATER TARGET TEMPERATURE BUT THE PATIENT BEING EXPIRED HAD NO CIRCULATION TO ALLOW AN INCREASE IN TEMPERATURE. THE WATER TEMPERATURE REACHED ITS MAXIMUM SETTING OF 42 DEGREES CELSIUS; HOWEVER, THE DEVICE'S THERAPY WAS DISCONTINUED PRIOR TO COMPLETION OF REWARMING THE PATIENT. THE DEVICE WOULD HAVE PROVIDED ADEQUATE THERAPY TO RAISE THE BODY TEMPERATURE; THE WATER TEMPERATURE WAS AT 42 DEGREES CELSIUS AND FLOW WAS ADEQUATELY PRESENTED THROUGHOUT THE PADS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IS INTENDED FOR MONITORING AND CONTROLLING PATIENT TEMPERATURE. WARNINGS AND CAUTIONS: WARNINGS: DO NOT USE THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IN THE PRESENCE OF FLAMMABLE AGENTS BECAUSE AN EXPLOSION AND/OR FIRE MAY RESULT. DO NOT USE HIGH FREQUENCY SURGICAL INSTRUMENTS OR ENDOCARDIAL CATHETERS WHILE THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IS IN USE. THERE IS A RISK OF ELECTRICAL SHOCK AND HAZARDOUS MOVING PARTS. THERE ARE NO USER SERVICEABLE PARTS INSIDE. DO NOT REMOVE COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. POWER CORD HAS A HOSPITAL GRADE PLUG. GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED ¿HOSPITAL USE¿ OR ¿HOSPITAL GRADE¿. WHEN USING THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, NOTE THAT ALL OTHER THERMAL CONDUCTIVE SYSTEMS, SUCH AS WATER BLANKETS AND WATER GELS, IN USE WHILE WARMING OR COOLING WITH THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM MAY ACTUALLY ALTER OR INTERFERE WITH PATIENT TEMPERATURE CONTROL. DO NOT PLACE ARCTICGEL PADS OVER TRANSDERMAL MEDICATION PATCHES AS WARMING CAN INCREASE DRUG DELIVERY, RESULTING IN POSSIBLE HARM TO THE PATIENT. CAUTIONS: THIS PRODUCT IS TO BE USED BY OR UNDER THE SUPERVISION OF TRAINED, QUALIFIED MEDICAL PERSONNEL. FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, BY OR ON THE ORDER OF A PHYSICIAN. USE ONLY DISTILLED OR STERILE WATER. THE USE OF OTHER FLUIDS WILL DAMAGE THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM. WHEN MOVING THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ALWAYS USE THE HANDLE TO LIFT THE CONTROLLER OVER AN OBSTACLE TO AVOID OVER BALANCING. THE PATIENT¿S BED SURFACE SHOULD BE LOCATED BETWEEN 30 AND 60 INCHES (75 CM AND 150 CM) ABOVE THE FLOOR TO ENSURE PROPER FLOW AND MINIMIZE RISK OF LEAKS. THE CLINICIAN IS RESPONSIBLE TO DETERMINE THE APPROPRIATENESS OF CUSTOM PARAMETERS. WHEN THE SYSTEM IS POWERED OFF, ALL CHANGES TO PARAMETERS WILL REVERT TO THE DEFAULT UNLESS THE NEW SETTINGS HAVE BEEN SAVED AS NEW DEFAULTS IN THE ADVANCED SETUP SCREEN. FOR SMALL PATIENTS (=30 KG) IT IS RECOMMENDED TO USE THE FOLLOWING SETTINGS: WATER TEMPERATURE HIGH LIMIT =40°C (104°F); WATER TEMPERATURE LOW LIMIT =10°C (64.4 °F); CONTROL STRATEGY =2. THE OPERATOR MUST CONTINUOUSLY MONITOR PATIENT TEMPERATURE WHEN USING MANUAL CONTROL AND ADJUST THE TEMPERATURE OF THE WATER FLOWING THROUGH THE PADS ACCORDINGLY. PATIENT TEMPERATURE WILL NOT BE CONTROLLED BY THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IN MANUAL CONTROL. DUE TO THE SYSTEM¿S HIGH EFFICIENCY, MANUAL CONTROL IS NOT RECOMMENDED FOR LONG DURATION USE. THE OPERATOR IS ADVISED TO USE THE AUTOMATIC THERAPY MODES (E.G. CONTROL PATIENT, COOL PATIENT, REWARM PATIENT) FOR AUTOMATIC PATIENT TEMPERATURE MONITORING AND CONTROL. THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM WILL MONITOR AND CONTROL PATIENT CORE TEMPERATURE BASED ON THE TEMPERATURE PROBE ATTACHED TO THE SYSTEM. THE CLINICIAN IS RESPONSIBLE FOR CORRECTLY PLACING THE TEMPERATURE PROBE AND VERIFYING THE ACCURACY AND PLACEMENT OF THE PATIENT PROBE AT THE START OF THE PROCEDURE. MEDIVANCE RECOMMENDS MEASURING PATIENT TEMPERATURE FROM A SECOND SITE TO VERIFY PATIENT TEMPERATURE. MEDIVANCE RECOMMENDS THE USE OF A SECOND PATIENT TEMPERATURE PROBE CONNECTED TO THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM TEMPERATURE 2 INPUT AS IT PROVIDES CONTINUOUS MONITORING AND SAFETY ALARM FEATURES. ALTERNATIVELY, PATIENT TEMPERATURE MAY BE VERIFIED PERIODICALLY WITH INDEPENDENT INSTRUMENTATION. THE DISPLAYED TEMPERATURE GRAPH IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO REPLACE STANDARD MEDICAL RECORD DOCUMENTATION FOR USE IN THERAPY DECISIONS. PATIENT TEMPERATURE WILL NOT BE CONTROLLED AND ALARMS ARE NOT ENABLED IN STOP MODE. PATIENT TEMPERATURE MAY INCREASE OR DECREASE WITH THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IN STOP MODE. CAREFULLY OBSERVE THE SYSTEM FOR AIR LEAKS BEFORE AND DURING USE. IF THE PADS FAIL TO PRIME OR A SIGNIFICANT CONTINUOUS AIR LEAK IS OBSERVED IN THE PAD RETURN LINE, CHECK CONNECTIONS. IF NEEDED, REPLACE THE LEAKING PAD. LEAKAGE MAY RESULT IN LOWER FLOW RATES AND POTENTIALLY DECREASE THE PERFORMANCE OF THE SYSTEM. THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM IS FOR USE ONLY WITH THE ARCTICGEL PADS. THE ARCTICGEL PADS ARE ONLY FOR USE WITH THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEMS. THE ARCTICGEL PADS ARE NON-STERILE FOR SINGLE PATIENT USE. DO NOT REPROCESS OR STERILIZE. IF USED IN A STERILE ENVIRONMENT, PADS SHOULD BE PLACED ACCORDING TO THE PHYSICIAN¿S REQUEST, EITHER PRIOR TO THE STERILE PREPARATION OR STERILE DRAPING. ARCTICGEL PADS SHOULD NOT BE PLACED ON A STERILE FIELD. USE PADS IMMEDIATELY AFTER OPENING. DO NOT STORE PADS ONCE THE KIT HAS BEEN OPENED. DO NOT PLACE ARCTICGEL PADS ON SKIN THAT HAS SIGNS OF ULCERATION, BURNS, HIVES, OR RASH. WHILE THERE ARE NO KNOWN ALLERGIES TO HYDROGEL MATERIALS, CAUTION SHOULD BE EXERCISED WITH ANY PATIENT WHO HAS A HISTORY OF SKIN ALLERGIES OR SENSITIVITIES. DO NOT ALLOW CIRCULATING WATER TO CONTAMINATE THE STERILE FIELD WHEN PATIENT LINES ARE DISCONNECTED. THE WATER CONTENT OF THE HYDROGEL AFFECTS THE PAD¿S ADHESION TO THE SKIN AND CONDUCTIVITY, AND THEREFORE, THE EFFICIENCY OF CONTROLLING PATIENT TEMPERATURE. PERIODICALLY CHECK THAT PADS REMAIN MOIST AND ADHERENT. REPLACE PADS WHEN THE HYDROGEL NO LONGER UNIFORMLY ADHERES TO THE SKIN. REPLACING PADS AT LEAST EVERY 5 DAYS IS RECOMMENDED. DO NOT PUNCTURE THE ARCTICGEL PADS WITH SHARP OBJECTS. PUNCTURES WILL RESULT IN AIR ENTERING THE FLUID PATHWAY AND MAY REDUCE PERFORMANCE. IF ACCESSIBLE, EXAMINE THE PATIENT¿S SKIN UNDER THE ARCTICGEL PADS OFTEN, ESPECIALLY THOSE AT HIGHER RISK OF SKIN INJURY. SKIN INJURY MAY OCCUR AS A CUMULATIVE RESULT OF PRESSURE, TIME AND TEMPERATURE. DO NOT PLACE BEAN BAG OR OTHER FIRM POSITIONING DEVICES UNDER THE ARCTICGEL PADS. DO NOT PLACE POSITIONING DEVICES UNDER THE PAD MANIFOLDS OR PATIENT LINES. THE RATE OF TEMPERATURE CHANGE AND POTENTIALLY THE FINAL ACHIEVABLE PATIENT TEMPERATURE IS AFFECTED BY MANY FACTORS. TREATMENT APPLICATION, MONITORING AND RESULTS ARE THE RESPONSIBILITY OF THE ATTENDING PHYSICIAN. IF THE PATIENT DOES NOT REACH TARGET TEMPERATURE IN A REASONABLE TIME OR THE PATIENT IS NOT ABLE TO BE MAINTAINED AT THE TARGET TEMPERATURE, THE SKIN MAY BE EXPOSED TO LOW OR HIGH WATER TEMPERATURES FOR AN EXTENDED PERIOD OF TIME WHICH MAY INCREASE THE RISK FOR SKIN INJURY. ENSURE THAT PAD SIZING / COVERAGE AND CUSTOM PARAMETER SETTINGS ARE CORRECT FOR THE PATIENT AND TREATMENT GOALS, WATER FLOW IS GREATER THAN OR EQUAL TO 2.3 LITERS PER MINUTE AND THE PATIENT TEMPERATURE PROBE IS IN THE CORRECT PLACE. FOR PATIENT COOLING, ENSURE ENVIRONMENTAL FACTORS SUCH AS EXCESSIVELY HOT ROOMS, HEAT LAMPS, AND HEATED NEBULIZERS ARE ELIMINATED AND PATIENT SHIVERING IS CONTROLLED. OTHERWISE, CONSIDER INCREASING MINIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT. FOR PATIENT WARMING, CONSIDER DECREASING MAXIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT. DUE TO UNDERLYING MEDICAL OR PHYSIOLOGICAL CONDITIONS, SOME PATIENTS ARE MORE SUSCEPTIBLE TO SKIN DAMAGE FROM PRESSURE AND HEAT OR COLD. PATIENTS AT RISK INCLUDE THOSE WITH POOR TISSUE PERFUSION OR POOR SKIN INTEGRITY DUE TO DIABETES, PERIPHERAL VASCULAR DISEASE, POOR NUTRITIONAL STATUS, STEROID USE OR HIGH DOSE VASOPRESSOR THERAPY. IF WARRANTED, USE PRESSURE RELIEVING OR PRESSURE REDUCING DEVICES UNDER THE PATIENT TO PROTECT FROM SKIN INJURY. DO NOT ALLOW URINE, ANTIBACTERIAL SOLUTIONS OR OTHER AGENTS TO POOL UNDERNEATH THE ARCTICGELPADS. URINE AND ANTIBACTERIAL AGENTS CAN ABSORB INTO THE PAD HYDROGEL AND CAUSE CHEMICAL INJURY AND LOSS OF PAD ADHESION. REPLACE PADS IMMEDIATELY IF THESE FLUIDS COME INTO CONTACT WITH THE HYDROGEL. DO NOT PLACE ARCTICGEL PADS OVER AN ELECTROSURGICAL GROUNDING PAD. THE COMBINATION OF HEAT SOURCES MAY RESULT IN SKIN BURNS. IF NEEDED, PLACE DEFIBRILLATION PADS BETWEEN THE ARCTICGEL PADS AND THE PATIENT¿S SKIN. CAREFULLY REMOVE ARCTICGELPADS FROM THE PATIENT¿S SKIN AT THE COMPLETION OF USE. DISCARD USED ARCTICGEL PADS IN ACCORDANCE WITH HOSPITAL PROCEDURES FOR MEDICAL WASTE. THE USB DATA PORT IS TO BE USED ONLY WITH A STANDALONE USB FLASH DRIVE. DO NOT CONNECT TO ANOTHER MAINS POWERED DEVICE DURING PATIENT TREATMENT. USERS SHOULD NOT USE CLEANING OR DECONTAMINATION METHODS DIFFERENT FROM THOSE RECOMMENDED BY THE MANUFACTURER WITHOUT FIRST CHECKING WITH THE MANUFACTURER THAT THE PROPOSED METHODS WILL NOT DAMAGE THE EQUIPMENT. DO NOT USE BLEACH (SODIUM HYPOCHLORITE) AS IT MAY DAMAGE THE SYSTEM. MEDIVANCE WILL NOT BE RESPONSIBLE FOR PATIENT SAFETY OR EQUIPMENT PERFORMANCE IF THE PROCEDURES TO OPERATE, MAINTAIN, MODIFY OR SERVICE THE MEDIVANCE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ARE OTHER THAN THOSE SPECIFIED BY MEDIVANCE. ANYONE PERFORMING THE PROCEDURES MUST BE APPROPRIATELY TRAINED AND QUALIFIED." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CODED AFTER INITIATING THERAPY ON AN ARCTIC SUN DEVICE AT WHICH POINT, THE PATIENT'S FAMILY DECIDED TO WITHDRAW CARE. THE DOCTOR WANTED THE PATIENT WARMED AS FAST AS POSSIBLE TO DECLARE BRAIN DEAD BUT THE PATIENT WOULD NOT WARM. THE PATIENT'S TEMPERATURE WAS 32.5 DEGREES CELSIUS. THE BARD SUPPORT REPRESENTATIVE PROVIDED ASSISTANCE ON HOW TO PROGRAM TO REWARM THE PATIENT AT MAXIMUM CAPACITY TO TARGET AS QUICKLY AS POSSIBLE. DURING TROUBLESHOOTING, THE BARD SUPPORT REPRESENTATIVE VERIFIED THE FLOW RATE WAS ADEQUATE AS WELL AS THE FIT OF PADS TO THE PATIENT. THE PATIENT EXPIRED DUE TO CARDIAC ARREST. THE FACILITY HAS INDICATED THAT THE DEVICE HAS NOT BEEN IMPLICATED IN THE PATIENT'S DEATH. THE PATIENT WAS ON THE ARCTIC SUN AT TIME OF DEATH. THE PATIENT CAME FROM THE EMERGENCY ROOM AND THE PATIENT'S HEART RATE DROPPED INTO THE 30'S THEN THE 20'S AND WENT INTO CARDIAC ARREST. THE NURSE CALLED THE SERVICE TEAM FOR HELP ON REWARMING THE PATIENT QUICKLY SO THE PATIENT COULD BE DECLARED DECEASED. THE PATIENT WAS NOT ON ANY VASOPRESSORS. THE NURSE MENTIONED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690199 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ARCTICSUN 5000 DWJ DYMAX CORP. -2523003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death