BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN 5000

    MDR report key: 7071547 · Received November 30, 2017

    Report

    Report Number
    1018233-2017-06192
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 25, 2018
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A CHILLER FAILURE. THE HGB VALVE RELAY WAS STUCK IN THE "OPEN" POSITION CAUSING THE INABILITY OF THE CHILLER TO COOL THE WATER. THE DECONTAMINATION TECHNICIAN ¿TAPPED¿ ON THE VALVE TO GET THE RELAY TO CLOSE. ONCE THE HGB VALVE CLOSED THE WATER WAS ABLE TO BE COOLED PROPERLY IN ORDER TO DECONTAMINATE THE DEVICE. THE CHILLER WAS REPLACED TO CORRECT THE REPORTED ISSUE. THE CONTROL PANEL PASSED CURRENT LEAKAGE TEST. DEVICE PASSED ACATS, LOW VOLTAGE TEST (FOR (B)(6) UNITS), AND ELECTRICAL SAFETY TESTS. THE ARCTIC SUN 5000 WAS SUBSEQUENTLY INSPECTED AND TESTED BY BES-DYMAX IN ACCORDANCE WITH BES-DYMAX STANDARD PROCESSES AND PROCEDURES AND, AFTER SERVICE, WAS FOUND TO FULLY COMPLY WITH ALL REQUIREMENTS AND SPECIFICATIONS. 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 A THERMAL REGULATING SYSTEM, INDICATED 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 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 (50 °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 SYSTEMS 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 SUPPLIES TEMPERATURE SIMULATORS (FIXED VALUE RESISTORS) FOR TESTING, TRAINING AND DEMONSTRATION PURPOSES. NEVER USE THIS DEVICE, OR OTHER METHOD, TO CIRCUMVENT THE NORMAL PATIENT TEMPERATURE FEEDBACK CONTROL WHEN THE SYSTEM IS CONNECTED TO THE PATIENT. DOING SO EXPOSES THE PATIENT TO THE HAZARDS ASSOCIATED WITH SEVERE HYPO- OR HYPER-THERMIA. 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 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 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 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 ARCTICGEL PADS. 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 ARCTICGEL PADS 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).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT CONTROLLING THE PATIENT'S TEMPERATURE DURING THE REWARM PHASE. THE PATIENT'S TEMPERATURE ROSE ABOVE 38 C AT A 35 C SETTING. ACCORDING TO THE DOCTOR, THE PATIENT'S CONDITION WAS NO BETTER THAN EXPECTED. THE PATIENT WAS POST CARDIAC ARREST. A FOLEY CATHETER WAS BEING USED TO MONITOR THE PATIENT'S TEMPERATURE. THE PATIENT WAS SWITCHED TO ANOTHER ARCTIC SUN DEVICE. IT WAS LATER REPORTED, THE PATIENT WAS IN A COMA AND ACCORDING TO THE DOCTOR, THE PATIENT WAS VERY SICK PRIOR TO THE START OF THERAPY. SO THE DOCTOR WAS UNSURE IF THE PATIENT'S CONDITION WAS CAUSED BY THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT CONTROLLING THE PATIENT'S TEMPERATURE DURING THE REWARM PHASE. THE PATIENT'S TEMPERATURE ROSE ABOVE 38 C AT A 35 C SETTING. ACCORDING TO THE DOCTOR, THE PATIENT'S CONDITION WAS NO BETTER THAN EXPECTED. THE PATIENT'S POST CARDIAC ARREST. A FOLEY CATHETER WAS BEING USED TO MONITOR THE PATIENT'S TEMPERATURE. THE PATIENT WAS SWITCHED TO ANOTHER ARCTIC SUN DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS IN A COMA AND ACCORDING TO THE DOCTOR, THE PATIENT WAS VERY SICK PRIOR TO THE START OF THERAPY. SO THE DOCTOR IS UNSURE IF THE PATIENT'S CONDITION WAS CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852475 ARCTIC SUN 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1