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Arctic Sun® Temperature Management System, Fill Tube 71800Recalls & reported problems

Medivance, Inc. · Arctic Sun® Temperature Management System, Fill Tube · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is the Medivance Arctic Sun fill tube, used to fill and drain the water pads on the Arctic Sun temperature management system, which controls a patient's body temperature. Most reports describe problems during filling: water that would not move through the tube, slow or partial filling, a clogged filter, brittle tubes, and water leaking from the device's base. Dirty water is also mentioned causing the level sensor to misread. There are 37 reports, no deaths and no injuries. No recalls name this part.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741080197), received between Nov 10, 2021 and Mar 6, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 5 reportsDec 2023: 6 reportsJan 2024: 6 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method18
  • Partial Blockage6
  • Defective Component4
  • Inaccurate Flow Rate4
  • Fitting Problem2
  • Restricted Flow rate2
  • Device Contamination with Body Fluid1
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions37

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2026Naturally Worn

    IT WAS REPORTED THAT THE PER WO EVALUATION, THERE WAS A FAULTY MIXING PUMP, FAULTY CIRCULATION PUMP AND FILLING TUBE WAS BRITTLE IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 05MAR2026, IT WAS REPORTED THAT THE COIN CELL NEEDING TO BE REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24531377 ↗
  • MalfunctionMar 7, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

    IT WAS REPORTED THAT THE AGILITY TEAM HAD THEIR ARCTIC SUN DEVICE. THE FILL TUBE HAD BLOOD IN IT. THEY SAID THEY COULD NOT CLEAN IT, SO THEY NEED TO KNOW WHAT TO DO. EXPLAINED THE FILL TUBE CIRCULATES WATER AND DID NOT COME INTO CONTACT WITH BLOOD. THE DISCOLORATION WAS LIKELY MICROORGANISMS. A NEW FILL TUBE MIGHT BE PURCHASED. ASKED NURSE TO CALL BACK WITH THE SN SO THE CORRECT PRODUCT CODE WAS PROVIDED. ASKED TO HAVE AGILITY REPLACE THE WATER IN THE CIRCULATION TANK TO ENSURE IT WAS CLEAN. INQUIRER FILL TUBE HAD BLOOD IN IT. THEY HAD ALREADY SPOKEN TO SOMEONE BUT NOW HAD PICTURES AND SN. EXPLAINED HOW THE DEVICE WORKED AND HOW IT WAS MORE THAN LIKELY MOLD OR MILDEW. SUGGESTED THEY DISPOSE OF THIS FILL TUBE AND ORDER ANOTHER. EXPLAINED HOW THEY HAVE TTM CUSTOMER SERVICE SO COULD ORDER THIS THROUGH AND WOULD CALL BACK WHEN READY TO ORDER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21547880 ↗
  • MalfunctionOct 7, 2024Restricted Flow rate; Insufficient Device Problem Information; Restricted Flow rate; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED TO REGULATE THE TEMPERATURE. PER SAMPLE EVALUATION RESULTS ON 01OCT2024, IT WAS REPORTED THAT THE LEVEL SENSOR NOT DETECTING WATER LEVEL DUE TO DIRTY WATER. FILL TUBE NEEDED TO BE REPLACED. PER WO UPDATED ON 07OCT2024, IT WAS NOTED THAT WHEN THEY TRIED TO FILL THE UNIT, THERE WAS NO MOVEMENT OF THE WATER FROM THEIR BOTTLE TO THE MACHINE BUT THERE WAS NORMAL NOISE COMING FROM THE PUMP. WHEN THEY CHECKED THE FILLING TUBE TRYING TO BLOW THROUGH IT, THAT WAS IMPOSSIBLE. TRIED TO CLEAN/WASH IT WITH HOT WATER AND SAME RESULTS SO THEY DECIDED TO CHANGE THE TUBE. AFTER THAT, THE UNIT WAS FILLED WITHOUT ANY PROBLEMS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20384946 ↗
  • MalfunctionJul 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO FILL PUMP IN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED ON 03JUL2024, IT WAS REPORTED THAT THE DIRTY FILL TUBE NOTED IN THE DEPOT REPAIR FINDINGS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19729494 ↗
  • MalfunctionMay 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE CONSIDERABLE AMOUNT OF WATER WAS LEAKING FROM THE BASE OF THE ARCTIC SUN DEVICE. NOT COMING FROM FLUID DELIVERY LINES OR FILL TUBE. WATER TEMPERATURE ON DEVICE WAS SHOWING 28 DEGREES SO NOT FROM CONDENSATION. THEY KEPT REPLACING THE TOWELS UNDER THE DEVICE. THEY HAD NOW SWAPPED OUT DEVICE AND NO FURTHER PROBLEMS AND PHOTOS WERE ATTACHED. PER REVIEW OF WO ON (B)(6) 2024, THE PATIENT WAS NOT INJURED BY THE DEVICE. DEVICE WAS SWAPPED OUT FOR THEIR SECOND ARCTIC SUN DEVICE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2024, THE UNIT FOUND THE ISSUE WITH WATER LEAKAGE. AND THE LEAKAGE RELATED TO BROKEN DRAIN VALVE. SO, THE ISSUE FIXED, AND THE UNIT WAS CURRENTLY DOING THE CALIBRATION. AND THE UNIT WOULD BE READY FOR PRODUCT RELEASE STATUS LATER TODAY. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON (B)(6) 2024, DEVICE REQUIRED COMES WITH ERROR 80 (NON-RECOVERABLE SYSTEM ERROR), CONFIRMED ITS RELATED TO THE PROCESSOR CIRCUIT CARD. THEY FOUND THE FILL TUBE WAS CONTAMINATED AND POWER CORD HAD HIGH RESISTANCE .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19381970 ↗
  • MalfunctionApr 4, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ALARMING THAT THERE WAS AN ERROR WITH THE PATIENT LINE AND WAS NOT FULLY FILLING THE PADS THEN WOULD NOT EMPTY THEM. PER INVESTIGATOR NOTIFICATION RECEIVED VIA TASK ON 21MAR2024, IT WAS REPORTED THAT THERE WAS A FAULTY TEMPERATURE CABLE AND WATER LEAK FROM DRAIN PORTS, SLOW FILLING DUE TO CLOGGED FILL TUBE FILTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19041074 ↗
  • MalfunctionMar 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THERE WAS NO FLOW AND NO DRAIN OF PADS IN AN ARCTIC SUN DEVICE. PER REVIEW OF (B)(6) ON (B)(6) 2024, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 07MAR2024, IT WAS REPORTED THAT THE FUNCTIONAL VERIFICATION TEST WAS OK. STRANGE SOUND FROM THE CIRCULATION PUMP. FILL TUBE WAS DIRTY , SCREEN PROTECTOR AND TEMPERATURE CABLE WERE MISSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18992864 ↗
  • MalfunctionMar 7, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THERE WAS LOW WATER FLOW PRESSURE IN THE ARCTIC SUN DEVICE. THE EQUIPMENT TURNED OFF. PLEASE DO A COMPREHENSIVE INSPECTION, INCLUDING REPLACING PUMPS AND FILTERS. PER SAMPLE EVALUATION RESULTS ON 15FEB2024. IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FILLED VERY SLOWLY. BOTH PUMPS WERE AT THE WEAR LIMIT, PREVENTIVE MAINTENANCE RECOMMENDED. FILL TUBE WAS DIRTY AND FILL TUBE MUST BE REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18855760 ↗
  • MalfunctionFeb 20, 2024Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT THE FILL TUBE NOT STAYING IN PLACE WAS AGAINST IFU AND CAUSES A HYGIENE RISK. THIS WORK ORDER HAS TO BE CREATED TO ENSURE FULL TRACEABILITY, BUT THE DEVICE WOULD NOT BE SENT IN FOR REPAIR. REPLACEMENT OF THE FILL TUBE WOULD NOT SOLVE THE ISSUE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 01FEB2024, THE ISSUE WAS RESOLVED WITH REPLACING THE FLUID DELIVERY LINE, DEVICE WILL NOT BE SENT IN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18739077 ↗
  • MalfunctionFeb 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD WEAK FLOW. PER SAMPLE EVALUATION RESULTS ON 08FEB2024, IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD DIRTY FILL TUBE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18704316 ↗
  • MalfunctionFeb 6, 2024Defective Component; Defective Component

    IT WAS REPORTED THAT CUSTOMER INFORMED THE ARCTIC SUN DEVICE NEEDED THE 2000 HOURS PREVENTIVE MAINTENANCE. PER SAMPLE EVALUATION RESULTS ON 18OCT2023, IT WAS REPORTED THAT THE DEFECTIVE CONTROL PANEL, MANIFOLD, FILL TUBE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18651635 ↗
  • MalfunctionFeb 5, 2024Defective Component; Defective Component

    IT WAS REPORTED THAT THE TRIAL ARCTIC SUN DEVICE SHIPPED ON 9TH AUGUST 2023 FOR 1 DAY MIS HELPLINE CALLED BY NURSING STAFF ON 11AUG2023. THE NURSE STATED THE DEVICE SEEMS TO BE STUCK ON THE FILL RESERVOIR SCREEN. THEY HAD CLEARED ALERT AND IT WAS CONTINUED POPPED UP EVEN THOUGH DEVICE WAS FILLED. THE NURSE HAD CYCLE POWER AND RESUMED THE THERAPY. THE DEVICE ALERTED 109 (ESOPHAGEAL PROBE RECOMMENDED - CONTROL STRATEGY 3 HAS BEEN CHOSEN WHICH ALLOWS THE PATIENT TARGET TEMPERATURE TO BE SET BETWEEN 32.0°C AND 32.9°C (89.6°F TO 91.2°F) AND THE TIMED THERAPY HAD FINISHED. THE NURSE STATED THE DEVICE WAS ON NORMO WITH TARGET TEMPERATURE OF 36C AND THEN THE TARGET TEMPERATURE ARE 33C WITH THE FOLEY PROBE CONNECTED. THE TECHNICIAN WAS THERE TO ASSIST WITH THE DEVICE. PER SAMPLE EVALUATION RESULTS ON 13OCT2023, IT WAS REPORTED THAT THE SLOW FILLING PROCESS HAS BEEN OBSERVED DUE TO FAULTY FILL IN TUBE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18639254 ↗
  • MalfunctionJan 22, 2024Nonstandard Device; Improper or Incorrect Procedure or Method; Nonstandard Device; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE SYSTEM TESTED ACCORDING TO THE SERVICE MANUAL. THE PUMPS, DRAIN VALVES AND HEATER HAVE BEEN REPLACED AND WAS WORKING CORRECTLY. THE ARCTIC SUN DEVICE DISPLAYED ERROR 1 (PATIENT LINE OPEN) WHEN THE CALIBRATION WAS IN PROGRESS. APPARENTLY, THE BYPASS VALVE DID NOT WORK IN CALIBRATION MODE. THE SYSTEM DID NOT PASS THE PREVENTIVE MAINTENANCE. PREVENTIVE MAINTENANCE REQUESTED. THE SYSTEM DID NOT RECORD FLOW AND NOT REACH TEMPERATURE. PER SAMPLE EVALUATION RESULTS ON 26DEC2023, IT WAS REPORTED THAT AFTER CALIBRATION, THE FLOWMETER STOPPED WORKING, THE POWER CORD HAD A CUT, AND THE FILL TUBE HAD MOLD ON IT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18551100 ↗
  • MalfunctionJan 19, 2024Partial Blockage; Partial Blockage

    THE CHILLER HAS FAILED AND NEEDS TO BE REPAIRED OR REPLACED (PROBABLY THE SECOND ONE). IN ADDITION, THERE MAY BE A NEW CHILLER PUMP AND THEN THE WHOLE DEVICE HAS TO GO THROUGH AN STK/MTK. PRIMARY WO TO THIS COMPLAINT IS (B)(4). PER SAMPLE EVALUATION RESULTS ON (B)(6) 2024, IT WAS REPORTED THAT THE CHILLER PUMP WAS FAULTY. SLOW FILLING DUE TO CLOGGED FILL TUBE FILTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18541634 ↗
  • MalfunctionJan 17, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE PREVENTIVE MAINTENANCE OF 2000HRS SERVICE DONE ON NOV18TH, ARCTIC SUN DEVICE WAS ENDING THERAPY RANDOMLY WITH NO APPARENT ISSUE. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2023, IT WAS REPORTED THAT THEY PUSHED THE CARD INTO THE SLOT AND SECURE IT IN THE CAGE WITH THE SCREW AND CHANGED THE LEVEL SENSOR. THEY PUT A SCREEN PROTECTION AND PERFORMED ALL TESTS. ERROR 80 (NON-RECOVERABLE SYSTEM ERROR) WAS OCCURRED SEVERAL TIMES AT POWER UP, AND IN THE LOG FILE THE 19 NOV. THEY FOUND THE INPUT AND OUTPUT CIRCUIT BOARD WAS UNPLUGGED IN THE SLOT BECAUSE THE 4 SCREWS WERE NOT FULLY SCREWED THAT WAS THE SCREWS THAT RETAINED THE CARDS IN THE CAGE AND ALSO HAVE A CRACK ON THE LEVEL SENSOR. PER SAMPLE EVALUATION RESULTS ON 04JAN2024, IT WAS REPORTED THAT THERE WAS A CRACK ON THE LEVEL SENSOR. IT WAS ALSO FOUND THAT THE FILL TUBE WAS DIRTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18524972 ↗
  • MalfunctionJan 17, 2024Partial Blockage; Partial Blockage

    IT WAS REPORTED THAT ARCTIC SUN DEVICE DID NOT COOLING. INITIAL PERFORMANCE EVALUATION WAS FAILED. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2024, IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD SLOW FILLING DUE TO CLOGGED FILL TUBE FILTER. A FAILED CHILLER PUMP CONTRIBUTED TO THE REPORTED ISSUE AND MISSING TEMPERATURE CABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18524746 ↗
  • MalfunctionJan 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THEY CHANGED MIXING, CIRCULATION PUMP, HEATER AND DRAINS VALVES BUT TEST TEMPERATURE FAILED OK FOR 30°C BUT WHEN THEY ASK TO COOL IT DID NOT WORK OR VERY LITTLE. PER SAMPLE EVALUATION RESULTS ON 29DEC2023, IT WAS REPORTED THAT THE LEVEL SENSOR WAS CRACKED AND FILL TUBE WAS DIRTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18502117 ↗
  • MalfunctionJan 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE TANK WAS EMPTY WHILE SCREEN SHOWING FULL UNABLE TO FILL WATER IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2023, IT WAS REPORTED THAT THE CRACK ON LEVEL SENSOR AND FILL TUBE DIRTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18446231 ↗
  • MalfunctionDec 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THEY HAD NO FLOW DURING STARTING THE ARCTIC SUN DEVICE. THEY ALSO HAD DRAINING ISSUE, LEAKING AND COLD WATER. AS PER FOLLOW UP INFORMATION RECEIVED ON 11DEC2023. THE DEVICE RETURNED TO A BD-APPROVED FACILITY FOR EVALUATION. CHANGE THE FLOW METER(FOR THE PB FLOW RATE =0, SO HEATING COMMAND) WORKS FINE AFTER AND CHANGE THE DRAIN VALVES FOR LEAKS RESOLVED., BUT DOES NOT REACH 6°C IN TIME (TESTED WITH ANOTHER MIXING PUMP AND CIRCULATION PUMP, INITIAL T4 WITH NO CIRCULATION 4,3 °C, 3.5 L IN TANK). CALIBRATION TEST UNIT CALIBRATION ERROR 82( WATER CHECK TIME OUT - OTHER CONDITION) (TESTED MANY TIME). INSUFFICIENT COOLING PERFORMANCE, NEED TO REPAIR. AS EVALUATION SUMMARY RECEIVED ON 05DEC2023. NO FLOW RATE ( FLOW RATE = 0, SO NO HEATER COMMAND), LEAKS AT DRAIN VALVES, NO SCREEN PROTECTION, FILL TUBE DIRTY, AFTER THE CHANGE OF FLOW METER AND DRAIN VALVES, THE FLOW RATE WORK AND THERE ARE NO MORE LEAKS. BUT T1 NOT DECREASE BELOW 6 °C IN TIME (30 MN, TESTED WITH ANOTHER MIXING PUMP AND CIRCULATION PUMP, INITIAL T4 WITH NO CIRCULATION 4,3 °C, 3.5 L IN TANK). CALIBRATION TEST UNIT CALIBRATION ERROR 82( WATER CHECK TIME OUT - OTHER CONDITION) INSUFFICIENT COOLING PERFORMAN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18398596 ↗
  • MalfunctionDec 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD INSUFFICIENT FLOW AND T° CABLE DAMAGED. PER SAMPLE EVALUATION RESULTS ON 27NOV2023, IT WAS REPORTED THAT THE CRACK ON LEVEL SENSOR AND FILL TUBE IS DIRTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18327031 ↗
  • MalfunctionDec 11, 2023Partial Blockage; Partial Blockage

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS VISUALLY INSPECTED, AND NO PHYSICAL DAMAGE WAS FOUND TO THE UNIT. FAULTY TEMPERATURE CABLE AND WATER LEAK FROM DRAIN PORTS, SLOW FILLING DUE TO CLOGGED FILL TUBE FILTER. PUMP HOURS WAS 2029 AND SYSTEM HOURS WAS 2641.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18300644 ↗
  • MalfunctionDec 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE SENSOR LEVEL CRACK. PER THE WO UPDATE ON 21NOV2023, IT WAS REPORTED THAT THE FILL TUBE WAS DIRTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18300441 ↗
  • MalfunctionDec 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD BEEN RETURNED TO DEPOT DUE TO BROKEN AND DAMAGED SCREWS AND DIRTY TANK. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14NOV2023.  REMOVE THE BROKEN BOLT, CHANGE THE LEVEL SENSOR, FILL TUBE, PUT A SCREEN PROTECTION AND PERFORM PREVENTIVE MAINTENANCE 2000 HOURS. DURING PREVENTIVE MAINTENANCE TEMPERATURE WAS NOT REACH TO 30°, TANK WAS FULL. PER SAMPLE EVALUATION RESULTS RECEIVED ON 20NOV2023, IT WAS REPORTED THAT THE DIRTY FILL TUBE. PER SAMPLE EVALUATION RESULTS RECEIVED ON 24OCT2023, IT WAS REPORTED THAT THE BLACK FOAM WAS DAMAGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18290982 ↗
  • MalfunctionDec 4, 2023Restricted Flow rate; Restricted Flow rate

    IT WAS REPORTED THAT THE DURING TESTING TO SEE IF THE ARCTIC SUN DEVICE WAS WORKING AND THEY REALIZED THAT THE FILL TUBE WAS NOT FILLING AND AFTER CHANGED IT THE PROBLEM WAS SOLVED. THE CIRCULATION PUMP, MIXING PUMP, HEATER AND DRAIN VALVES ARE CHANGED AND THE DEVICE WAS CALIBRATED. PREVENTIVE MAINTENANCE WAS PERFORMED CORRECTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18258181 ↗
  • MalfunctionNov 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT CHANGING THE LEVEL SENSOR IN ARCTIC SUN DEVICE, THE FILL TUBE AND PERFORM THE PREVENTIVE MAINTENANCE 2000HOURS (CLEANING, CHANGING CIRCULATION AND MIXING PUMP, HEATER AND DRAIN VALVES, CALIBRATION TEST UNIT CALIBRATION), ALL OVER TESTS. AS PER EVALUATION SUMMARY THE LEVEL SENSOR WORK AT THIS TIME BUT THERE'S A CRACK ON THE LEVEL SENSOR. THE FILL TUBE WAS DIRTY. CHANGING LEVEL SENSOR, FILL TUBE AND PERFORM PREVENTIVE MAINTENANCE 2000HOURS. CALIBRATION TEST UNIT CALIBRATION. ALL TEST RESULTS ARE PASSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18216537 ↗

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