Arctic Sun® Temperature Management System, ArcticGel™ Pads 31700Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741080005), received between Mar 9, 2021 and Apr 11, 2026 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Restricted Flow rate

  IT WAS REPORTED BIOMED HAD THE ARCTIC SUN DEVICE THAT'S GIVING THEM AN ALARM 41 BUT IT WAS ALSO GIVING THE NURSES A 113 ALERT. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 09MAR2026, BIOMED HAD DEVICE GIVING ALARM 41 LOW INTERNAL FLOW. PER REVIEW OF WO NOTES ASKED BIOMED IF THE DEVICE HAD ANY PADS OR SHUNT ATTACHED, THEY SAID "BLUE HOSES" THEY ASKED IF THERE WERE PADS AT THE END OF THE BLUE HOSES AND THEY SAID NO JUST THE HOSES, ASKED BIOMED TO REMOVE THEM AND WAS GOING TO RUN A FUNCTIONAL CHECK AND CALL BACK. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 11MAR2026, PER WORK ORDER UPDATE, BIOMED RAN FUNCTIONAL CHECK AND PASSED WITHOUT ANY ISSUES, SAID THEY WOULD RETURN IT TO THE FLOOR SINCE IT WAS MOST LIKELY THE PAD TUBES TORN OFF THE PADS THEY HAD ON THE END OF THE FDL. PER ADDITIONAL INFORMATION RECEIVED VIA TTM ON 10MAR2026, BIOMED WAS TOLD TO RUN A PERFORMANCE VERIFICATION AND CALL BACK. PER ADDITIONAL INFORMATION RECEIVED VIA TTM ON 07APR2026, IT WAS REPORTED THAT THEY WERE GETTING ALARMS IN AN ARCTIC SUN DEVICE THAT WOULD NOT CLEAR AND DID NOT SEE ANY WATER MOVING IN THE PADS. CONFIRMED ALARM 01 (PATIENT LINE OPEN) AND ALARM 02 (LOW FLOW) IN THE EVENT LOG. FLOW RATE (FR)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850169 ↗
• InjuryMay 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THEY NEED SOME EDUCATION ON THE ARCTIC SUN DEVICE. ALSO, HOW TO PULL DATA FROM THE ARCTIC SUN. THEY RECENTLY HAD A PATIENT THAT HAD BURNS FROM THE ARCTIC GEL PADS AND TRYING TO DETERMINE IF SOMEONE JUST WARMED THE PATIENT WITHOUT THE REWARM PHASE OR WHAT EXACTLY HAPPENED. THERAPY WAS ON AND OFF FOR SEVERAL DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 22095430 ↗
• MalfunctionFeb 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE STATED THAT THEY WERE TRYING TO START THERAPY ON A PATIENT. THE ARCTIC SUN DEVICE WAS ALARMING 01 PATIENT LINE OPEN. THEY TRIED DISCONNECTING AND RECONNECTING THE PADS AND THEN REBOOTING THE DEVICE. CURRENT WATER FLOW RATE (WFR) WAS 0. CONFIRMED THEY WERE USING A NEONATAL PAD AND A UNIVERSAL PAD. HAD NURSE STOP THERAPY, EMPTY THE PADS, AND DISCONNECT THE PADS. WALKED NURSE THROUGH PLACING DEVICE IN MANUAL CONTROL. WITHOUT PADS WATER FLOW RATE (WFR) WAS 1.9 L/MIN, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 51 PERCENTAGE, SYSTEM HOURS WERE 8,376, AND PUMP HOURS WERE 7,424. HAD NURSE CONNECT NEONATAL PAD, WATER FLOW RATE (WFR) WAS 1.3 L/MIN, INLET PRESSURE (IP) WAS -0.7PSI, AND CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. NURSE CONFIRMED PAD CONNECTION CLICKED IN; TUBING WAS STRAIGHT. HAD NURSE DISCONNECT PAD AND TRY CONNECTING TO ANOTHER PORT, WATER FLOW RATE (WFR) WAS 1.2 L/MIN, INLET PRESSURE (IP) WAS -0.6PSI, AND CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. NURSE MIGHT BE HEARING A HISSING SOUND COMING FROM THE PAD. HAD NURSE DISCONNECT NEONATAL PAD AND CONNECT THE UNIVERSAL PAD, WATER FLOW RATE (WFR) WAS 0.8 L/MIN,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364959 ↗
• MalfunctionJan 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ANOTHER ARCTIC GEL PAD FAILED ON (B)(6) 2025. SOUNDS VERY SIMILAR TO THEIR OTHER RECENT FAILURE. WHEN THEY WENT TO TURN THE PATIENT, PARTS OF THE PAD HAD SORT OF DISSOLVED AND THE PATIENT WAS IN GOO. NOTHING WAS BETWEEN THE SKIN AND PAD AND NOT SURE HOW LONG THEY WERE ON BUT WOULD TIME AND DATE THEM MOVING FORWARD. ADDITIONAL CLEANING OF PATIENT AND LINENS, USE OF ADDITIONAL PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265013 ↗
• MalfunctionDec 20, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE STATED THAT THEY WERE TRYING TO START THERAPY ON A PATIENT IN AN ARCTIC SUN DEVICE. THEY KEEP RECEIVING A LOW FLOW ALARM 01 AND 02. THEY HAVE TRIED SWITCHING THE MACHINE OUT, BUT THEY WERE GETTING THE SAME ALARM. NURSE PROVIDED S/N (B)(6) FOR CURRENT MACHINE. CONFIRMED THEY HAVE A SET OF 4 PADS AND A UNIVERSAL PAD CONNECTED. HAD NURSE STOP, EMPTY PADS, AND DISCONNECT PADS. HAD NURSE CONFIRM NO KINKS OR BENDS IN TUBING, RECONNECTED PADS WITH PROPER TECHNIQUE. RESUMED THERAPY, DEVICE PRIMED TO WATER FLOW RATE (WFR) WAS 0 L/MIN. HAD NURSE STOP, EMPTY THE PADS AND DISCONNECT. WALKED NURSE THROUGH PLACING DEVICE IN MANUAL CONTROL. WITHOUT PADS, WATER FLOW RATE (WFR) WAS 2.1 L/MIN, INLET PRESSURE (IP) WAS -8.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 79 PERCENTAGE, SYSTEM HOURS 5,026, AND PUMP HOURS 4,307. HAD NURSE CONNECT ONE PAD AT A TIME, RIGHT CHEST, WFR 1.8 L/MIN, INLET PRESSURE (IP) WAS -2.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. ADDED RIGHT LEG, WATER FLOW RATE (WFR) WAS 1.4 L/MIN, INLET PRESSURE (IP) WAS -2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. ADDED LEFT LEG, WATER FLOW RATE (WFR) WAS 1.4 L/MIN, INLET PRESSURE (IP) W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20987010 ↗
• MalfunctionDec 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT 4 Y/O PATIENT ON ARCTIC SUN DEVICE S/N #(B)(6) FOR NORMOTHERMIA. THE PATIENT SPIKED A FEVER A FEW TIMES BUT WAS NOW BELOW TARGET AND CONTINUES TO DROP. THE WATER DID NOT SEEM TO BE HEATING UP. THE PATIENT TEMPERATURE (PT) WAS 35.3C, TARGETED TEMPERATURE (TT) WAS 37C. THE WATER WAS NOT GETTING ABOVE 23C. THEY TURNED THE DEVICE OFF BECAUSE THE PATIENT WAS GETTING COLDER. ASKED NURSE TO TURN THE DEVICE BACK ON. ASKED IF THEY RECALLED THE FLOW RATE AND THEY THOUGHT IT WAS GOOD, AROUND 2.3LPM. DEVICE IN NORMOTHERMIA WITH A REWARM RATE OF 0.25C/HR. EXPLAINED IF THE PROVIDER AGREES, THE REWARM RATE MAY BE ADJUSTED TO 0.5C/HR. CHECKED EVENT LOG, ALARM 02 (LOW FLOW) AND ALARM 113 (REDUCED WATER TEMPERATURE CONTROL) IN EVENT LOG. NURSE SAYS THEY WENT OFF ONCE A LONG TIME AGO, BUT NOT RECENTLY. ASKED NURSE TO KEEP DEVICE RUNNING AND CALL BACK IF THEY GET ANY ALARMS AND THEY WOULD FOLLOW UP IN AN HOUR. THE DEVICE SEEMS TO BE WARMING THE PATIENT AT 0.25C/HR SO THE WATER DID NOT NEED TO BE THAT WARM TO PREVENT WARMING TOO QUICKLY. NURSE CALLED BACK 30 MINUTES LATER. DEVICE WAS GIVING ALERT 113 AND THE PATIENT TEMPERATURE WAS NOW 34.9C, WATER TEMPERATURE (WT) WAS 26.C. HEATER

  Patient problems: Fever

  MAUDE report 20846832 ↗
• MalfunctionAug 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE STATED THAT THE PATIENT HAS BEEN ON THERAPY FOR A WHILE, BUT NOW THERE WAS NO WATER FLOW IN AN ARCTIC SUN DEVICE. HAD CUSTOMER RESTART THERAPY AND GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 2439, PUMP HOURS WERE 1960, INLET PRESSURE (IP) WAS -7, CIRCULATION PUMP COMMAND (CPC) WAS 42 PERCENTAGE, FLOW RATE (FR) WAS 1.5LPM. CONFIRMED THEY ALREADY TRIED DISCONNECTING AND RECONNECTING PADS PRIOR TO THE CALL. THIS MIGHT HAVE RESOLVED THE FLOW RATE (FR) ISSUE. PATIENT HAD FOUR UNIVERSAL PADS ON (NURSE WAS UNSURE WHY IT WAS DONE THIS WAY). PATIENT WAS 64KG. SUGGESTED ADDING A UNIVERSAL PAD TO THE ABDOMEN FOR GREATER FLOW RATE (FR) WAS AND BETTER PAD COVERAGE. ADDED UNIVERSAL PAD AND FLOW RATE (FR) WAS INCREASED TO 2.2LPM, INLET PRESSURE (IP) WAS -7.3, CIRCULATION PUMP COMMAND (CPC) WAS 51 PERCENTAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077541 ↗
• MalfunctionJul 9, 2024Use of Device Problem; Lack of Effect; Use of Device Problem; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT ON NORMOTHERMIA AND IT DID NOT SEEM TO BE GETTING TO TARGETED TEMPERATURE (TT) IN AN ARCTIC SUN DEVICE. TARGETED TEMPERATURE (TT) WAS 35C, PATIENT TEMPERATURE (PT) WAS 33C, WATER TEMPERATURE (WT) WAS 36.9-39.9C, FLOW RATE (FR) WAS 2/5L/M. THERE WAS ONLY ALERT ~7 HOURS EARLIER (ALARM 15- UNABLE TO OBTAIN A STABLE PATIENT TEMPERATURE). PATIENT WEIGHT WAS 99KG, PAD SIZE WAS M. EXPLAINED THAT WITHOUT ADEQUATE PAD COVERAGE THE PATIENT MIGHT NOT REACH THE TARGET TEMPERATURE. IF THERE WAS NOT PROPER PAD COVERAGE THE WATER TEMPERATURE (WT) MIGHT GET TOO HOT OR COLD TO COMPENSATE. BASED ON PATIENT'S WEIGHT - THE LARGE PADS MIGHT BE A BETTER FIT (73-100KG). DISCUSSED WITH INQUIRER HOW THE DEVICE WAS FUNCTIONING APPROPRIATELY. REMINDED RN TO DO DILIGENT SKIN CHECKS AND CALL BACK WITH ANY QUESTIONS. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 15JUL2024, SPOKE WITH NURSE WHO STATED THAT THEY HAD DECIDED TO ADD ONE UNIVERSAL PAD TO THE PATIENT'S ABDOMEN INSTEAD OF EXCHANGING TO A LARGER PAD SET. WITH THE ADDITIONAL UNIVERSAL PAD, THE PATIENT WAS ABLE TO MEET TARGET TEMPERATURE AS EXPECTED. PATIENT COMPLETED THERAPY WITH NO FURTHER ISSUES. ALL PADS AND PROBES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702482 ↗
• MalfunctionMay 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THEY AWARE OF THE PAD ISSUE IN THE (B)(6) NEONATAL INTENSIVE CARE UNIT (NICU). THEY CAME UPON TWO MORE SETS AND WITH THE SAME ISSUE THIS WEEK ON 9SE. THESE PADS DID NOT STICK EITHER, PEELED BACK ON TO THEMSELVES ON SEVERAL PADS AND AS THE WATER TEMPERATURES FLUCTUATED, THE GEL CAME OFF THE PADS AND ON TO THE PATIENT, ALMOST IN A MELTING FASHION. THEY WERE NOT SURE IF THERE HAS BEEN A DIFFERENT MANUFACTURER OVER THE LAST FEW YEARS AND THE PADS HAVE BEEN GETTING WORSE AND WORSE THAT WAS MATERIAL COMING OFF AROUND THE HOSES AND THEN PADS NOT STICKING TO THE PATIENT, BUT THIS WAS THE WORST CONDITION THEY HAVE SEEN THEM. THEY CONCERNED SINCE IT WAS TWO DIFFERENT UNITS AND BUILDINGS AND MOST LIKELY TWO DIFFERENT LOTS. THE PICTURE OF THE BELOW WAS PEEL BACK FROM THE PADS ON 9SE, BUT THEY DID NOT HAVE THE LOT NUMBER OF THESE PADS. OTHER PICTURES BELOW WERE THE PADS FROM THE (B)(6) NEONATAL INTENSIVE CARE UNIT (NICU) BEING HELD TOGETHER, AND THE PACKAGING, LOT #NGHY5076.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229249 ↗
• InjuryJan 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN ADVERSE EVENT WHEN THE ARCTIC GEL PADS WERE REMOVED DURING POST-MORTEM CARE. THE CUSTOMER STATED THERE WERE SIGNIFICANT LOOKING BURNS WITH THE TOP LAYER OF SKIN GONE. THEY HELD ON TO PADS FOR RETURN TO BD. THE CUSTOMER EXPLAINED THAT THE PATIENT¿S SKIN WAS SEVERELY DAMAGED AND SHARED THAT IT WAS THE UPPER TORSO, FRONT OF CHEST, ABDOMEN, AND THIGHS EVERYWHERE. THEY DISCUSSED THAT THERE WAS A LONGER PERIOD OF REWARMING. THE DEVICE MIGHT HAVE BEEN RUNNING AT A HIGHER TEMPERATURE FOR A WHILE, BUT THEY DIDN'T THINK IT WAS ENOUGH TO BURN AT THAT PERIOD OF TIME DURING REWARMING. THE ARCTIC SUN DEVICE HAD BEEN REMOVED FROM SERVICE DURING AN INTERNAL INVESTIGATION. PER FOLLOW UP VIA EMAIL ON 08JAN2024, THE INTENSIVE CARE UNIT (ICU) CLINICAL MANAGER STATED AN INTERNAL REVIEW WAS BEING CONDUCTED, AND NO ADDITIONAL INFORMATION COULD BE PROVIDED. ADDITIONAL FOLLOW UPS WERE ATTEMPTED VIA PHONE ON 24-JAN-2024 AS WELL AS VIA EMAIL ON 17-JAN-2024 AND 24-JAN-2024. THE ICU CLINICAL MANAGER WAS STILL UNABLE TO PROVIDE DETAILS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08-FEB-2024, STAFF AT THE FACILITY RECEIVED EDUCATION IN 2022, AND EDUCATION

  Patient problems: Burn(s); Skin Tears

  MAUDE report 18541957 ↗
• MalfunctionNov 27, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT NURSE JUST STARTED SHIFT AND THE ARCTIC SUN DEVICE HAD BEEN ALERTING SINCE IT ARRIVED. PATIENT HAD BEEN ON THERAPY LESS THAN AN HOUR AND THEY BELIEVED ISSUE HAD BEEN OCCURRING SINCE STARTED. ALERT 02 LOW FLOW. WATER FLOW RATE WAS CURRENTLY 0 L/M, 4 PADS CONNECTED. TRIED TO RESTART THERAPY, BUT DEVICE PRIMED TO 0 L/M WORKFLOW RATE. HAD THEM PRESS STOP THERAPY, DRAIN PADS AND DISCONNECT. VERIFIED FLUID DELIVERY LINE WAS SECURE. RECONNECTED PADS HOLDING NOWHERE NEAR CLEAR CONNECTORS AND VERIFIED AUDIBLE CLICKS WITH EACH CONNECTION. ALL LINES STRAIGHT WITH NO BENDS OR KINKS. RESTARTED THERAPY AND DEVICE AGAIN PRIMED TO 0 L/M WATER FLOW RATE. DEVICE THEN ALERTED FLUID DELIVERY LINE WAS OPEN. SYSTEM DIAGNOSTICS READ OUTLET MONITOR TEMPERATURE WAS 10.2C, OUTLET CONTROL TEMPERATURE WAS 10.2C, INLET TEMPERATURE WAS 19.6C, CHILLER TEMPERATURE WAS 6C, WATER FLOW RATE WAS 0 L/M, INLET PRESSURE WAS -4.6PSI, CIRCULATION PUMP COMMAND WAS 100 PERCENTAGE, MIXING PUMP COMMAND WAS 18, HEATER WAS 0, WATER RESERVOIR LEVEL WAS 5, SYSTEM HOURS WERE 1215.5 AND PUMP HOURS WERE 558. WALKED THROUGH STOP THERAPY DRAIN AND DISCONNECT PADS. PLACED DEVICE IN MANUAL CONTROL AT 10C. AFTER A FE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211054 ↗
• MalfunctionOct 3, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE HAD A PATIENT IN NORMOTHERMIA ON THE ARCTIC SUN DEVICE. NURSE STATED THAT THEY RECEIVED ALERT 02 (LOW FLOW) AND ALERT 01 (AIR LEAK) ALARMS. THEY COULD HEAR A CRINKLING SOUND FROM THE RIGHT CHEST PAD AS THE NURSE BELIEVED AND STATED THAT THE THERAPY WAS DUE TO END AROUND 1800 THIS EVENING, SO THEY WERE TRIED TO AVOID CHANGING THE PADS COMPLETELY. THEY HAVE TRIED EMPTYING THE PADS, DISCONNECTING AND RECONNECTING, AND STRAIGHTENING OUT THE TUBING. WATER FLOW RATE (WFR) WAS 1.7 L/MIN, THEY HAVE 5 PADS CONNECTED. CONFIRMED THE PATIENT HAD NOT BEEN TO IMAGING OR PROCEDURES, HOWEVER THEY DID JUST RECENTLY FINISH TURNING THE PATIENT. HAD NURSE PAUSE THERAPY, EMPTY THE PADS AND DISCONNECT ALL 5 PADS. WALKED NURSE THROUGH PLACING THE DEVICE IN MANUAL CONTROL. WITH NO PADS CONNECTED, WATER FLOW RATE (WFR) WAS 1.8 L/MIN, INLET PRESSURE (IP) WAS -7 PSI, CIRCULATION PUMP COMMAND (CPC) WAS 46 PERCENTAGE. INFORMED NURSE WHEN THEY CONNECTED THE PADS, MAKE SURE THEY HOLD THE BLUE TUBING AND NOT THE CLEAR PLASTIC CLAMPS PIECES, LISTENING FOR AUDIBLE CLICKS. NURSE ADDED ONE LEG PAD, WATER FLOW RATE (WFR) WAS 0.8 L/MIN, INLET PRESSURE (IP) WAS -7.4 PSI, CIRCULATION PUMP C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860775 ↗
• MalfunctionOct 3, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE HAD A PATIENT IN NORMOTHERMIA ON THE ARCTIC SUN DEVICE. NURSE STATED THEY WAS RECEIVING LOW FLOW AND AIR LEAK ALARMS. THEY COULD HEAR A CRINKLING SOUND FROM THE RIGHT CHEST PAD THEY BELIEVED. NURSE STATED THERAPY WAS DUE TO END AROUND 1800 THAT EVENING, SO THEY WERE TRYING TO AVOID CHANGING THE PADS COMPLETELY. THEY HAD TRIED EMPTYING THE PADS, DISCONNECTED, RECONNECTED AND STRAIGHTENED OUT THE TUBING. WATER FLOW RATE WAS 1.7 L/MIN, THEY HAD FIVE PADS CONNECTED. IT WAS CONFIRMED THE PATIENT HAD NOT BEEN TAKEN TO IMAGING OR PROCEDURES, HOWEVER THEY RECENTLY FINISHED TURNING THE PATIENT. HAD NURSE PAUSE THERAPY, EMPTY THE PADS AND DISCONNECT ALL FIVE PADS. WALKED NURSE THROUGH PLACING THE DEVICE IN MANUAL CONTROL. WITH NO PADS CONNECTED, WATER FLOW RATE WAS 1.8 L/MIN, INLET PRESSURE WAS -7 PSI AND CIRCULATION PUMP COMMAND WAS 46 PERCENTAGE. INFORMED NURSE WHEN THEY CONNECT THE PADS TO MADE SURE THEY HELD THE BLUE TUBING AND NOT THE CLEAR PLASTIC CLAMPS PIECES AND LISTENED FOR AUDIBLE CLICKS. NURSE ADDED ONE LEG PAD, WATER FLOW RATE WAS 0.8 L/MIN, INLET PRESSURE WAS -7.4 PSI AND CIRCULATION PUMP COMMAND WAS 23 PERCENTAGE. HAD NURSE CONNECT SECOND LEG PAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860182 ↗
• MalfunctionAug 14, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE JUST GOT ON SHIFT AND ARCTIC SUN DEVICE WAS ALERTING AIR LEAK AND LOW FLOW. THEY HAVE DRAINED PADS AND DEVICE ALERTED LOW RESERVOIR. ADDED WATER. RESTARTED AND DEVICE ALERTED AGAIN AND THEN THERAPY STOPPED. PATIENT TEMPERATURE (PT) WAS 37.1C, TARGETED TEMPERATURE (TT) WAS 36.5C, WATER FLOW RATE (WFR) WAS 0 L/M IN NORMOTHERMIA. MEDIUM PADS AND UNIVERSAL PADS CONNECTED. PATIENT HAD BEEN ON THERAPY FOR 29 HOURS. NURSE CONFIRMED THAT THE PATIENT HAD BEEN TO MRI TWICE PER NOTES. HAD EMPTIED PADS AND DISCONNECT. PLACED DEVICE IN MANUAL CONTROL AT 10C. SYSTEM DIAGNOSTICS WITH NO PADS WERE OUTLET MONITOR TEMPERATURE (T1) WAS 12.5C, OUTLET CONTROL TEMPERATURE (T2) WAS 12.5C, INLET TEMPERATURE (T3) WAS 16.3C, CHILLER TEMPERATURE (T4) WAS 3.8C, WATER FLOW RATE (WFR) WAS 1.7 L/M, INLET PRESSURE (IP) WAS -7.2 PSI, CIRCULATION PUMP COMMAND (CPC) WAS 46PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 18PERCENTAGE, HEATER WAS 0, WRL 5, SYSTEM HOURS WERE 646.6, PUMP HOURS WERE 525.6. ADVISED ALERTS APPEARED TO BE RELATED TO THE PADS AND DISCUSSED TROUBLE SHOOTING THE PADS INDIVIDUALLY. NURSE WAS GOING TO SWAP OUT PADS INSTEAD TO GET PATIENT BACK ON THERAPY. ONLY HAD A SIZE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540010 ↗
• InjuryMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT TRANSFERRED FROM CENTENNIAL MEDICAL CENTER TO SKYLINE MEDICAL CENTER THAT HAD VERY BAD SKIN BURNS ON THEIR BODY FROM WHAT WAS DESCRIBED AS THE UNIVERSAL PADS ON THE ARCTIC SUN DEVICE. NURSE STATED THAT THE PATIENT¿S SKIN HAD BEEN BURNED BY THE ARCTIC GEL PADS DURING THERAPY. THEY WERE DOING SKIN GRAFTS ON THIS PATIENT. THE BURNS WERE ON THE SKIN UNDER THE OUTLINE OF GEL PADS. THEY DO NOT HAVE A CONFIRMATION IN DETAIL, BUT THIS SHOULD BE INVESTIGATED.

  Patient problems: Burn(s); Burning Sensation

  MAUDE report 16918993 ↗
• InjuryAug 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CUSTOMER WAS REACHING OUT ABOUT ANY SKIN ISSUES THAT CAN OCCUR WHILE USING THE ARCTIC GEL PADS. CUSTOMER STATED THAT THEY CALLED TO GATHER SOME INFORMATION ABOUT PREVENTING PRESSURE INJURY WITH THE ARTIC SUN PADS. NURSE HAD TWO PRESSURE INJURIES FROM THE PADS, AND IT CAME UP IN A DISCUSSION WHETHER THEY COULD PLACE A MEPILEX LITE UNDER THE BORDERS OF THE PADS. MSS WAS NOT SURE THOUGH IF THIS WOULD INTERFERE WITH THE DEVICE. EVENT OCCURRED PRIOR TO STARTING THIS POSITION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 15307860 ↗
• MalfunctionJul 5, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT PATIENT WAS BEING MAINTAINED AT 35C ON THE ARCTIC SUN DEVICE. THE PATIENT RETURNED FROM COMPUTED TOMOGRAPHY (CT) AND NOW THE FLOW RATE WAS 0.1LPM AND THEY WERE RECEIVING ALERT 01 AND ALERT 02 (PATIENT LINE OPEN AND LOW FLOW). THEY HAVE EMPTIED, DISCONNECTED, AND RECONNECTED THE ARCTIC GEL PADS. THE RESERVOIR WAS FULL AND DID NOT TAKE UP ANY WATER WHEN THEY TRIED TO FILL IT. INLET PRESSURE WAS -2.3PSI AND PUMP HOURS WERE 836. NURSE REMOVED THE LEFT THIGH PAD, BUT THE INLET PRESSURE REMAINED -2 TO -3PSI. NURSE REPLACED LEFT THIGH PAD AND REMOVED THE RIGHT THIGH PAD. INLET PRESSURE REMAINED -2 TO -3PSI. THE SAME WHEN THE UNIVERSAL PAD WAS REMOVED. NURSE STOPPED THERAPY, EMPTIED, AND DISCONNECTED PADS AND PLACED DEVICE IN MANUAL MODE. FLOW RATE WAS 1.9LPM, INLET PRESSURE WAS -6.9PSI. MSS SUGGESTED REPLACING THE PADS (LOT#NGGQ1696 AND UNIVERSAL WAS LOT#NGGP2639 ) AND PATIENT TEMPERATURE WAS 34.6C. NURSE WOULD SPEAK TO THE DOCTOR TO SEE IF THEY WANT TO REPLACE THE PADS OR TRY TO CONTROL THE PATIENT TEMPERATURE USING OTHER MEANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914481 ↗
• MalfunctionMay 13, 2022Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE ARCTIC GEL PAD TUBE WAS BROKEN WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397305 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW MONTHS AGO THE PATIENT WAS IN BURN INTENSIVE CARE UNIT AND USED ARCTIC GEL PADS ON PATIENT AND THERE WAS A SKIN INJURY. THEY WERE NOT SURE WHETHER THE SKIN WAS INTACT PRIOR PLACING THE PADS ON THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2022, THERE WAS PATIENT INVOLVEMENT DURING REPORTED EVENT AND PATIENT REQUIRED SURGERY. THE PHYSICIAN TOOK PATIENT TO THE OPERATING ROOM FOR MULTIPLE DEBRIDEMENT AND PLACEMENT OF AUTOGRAFT. THE THERAPY STOPPED AFTER IT WAS NOTED THAT FROST BITE OCCURRED. THE PATIENT SUSTAINED INHALATION INJURY, ARCTIC SUN PADS WERE NOT APPLIED TO PATIENT SKIN WITH BURNS, AND PATIENT WAS INTUBATED AND SEDATED. THE PADS WERE DISPOSED AND NOT AVAILABLE FOR RETURN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14383010 ↗
• MalfunctionApr 22, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT RETURNED FROM CATHETERIZATION LAB PROCEDURE AFTER CHEST COMPRESSIONS IMPLEMENTED WITH UNIVERSAL PAD IN PLACE ON THE ARCTIC SUN DEVICE. THEY RECEIVED AN ALERT 01 (PATIENT LINE OPEN) AND ALERT 02 (LOW FLOW) WAS NOTED. THE PATIENT THERAPY WAS STOPPED DUE TO PATIENT STATUS AND AFTER PATIENT RETURNED FROM CATHETERIZATION LAB THE THERAPY WAS REINITIATED. THEN THEY OBSERVED THE ALERTS 01 (PATIENT LINE OPEN) AND ALERT 02 (LOW FLOW). MSS WALKED THE NURSE THROUGH DISCONNECTING AND RECONNECTING PADS USING PROPER TECHNIQUE. THE REGISTERED NURSE EMPTIED ARCTIC GEL PADS AND RESTARTED THERAPY AND AFTER WAITING 2 MINUTES THE FLOW RATE WAS STILL LOW FLOW. MSS EXPLAINED TO NURSE HOW TO CHECK FOR DAMAGED PAD AND UNIVERSAL PAD WAS DISCONNECTED AND FLOW RATE ROSE UP TO 2.1 L/MIN. THE REGISTERED NURSE STATED THEY WOULD REPLACE UNIVERSAL PAD AND CALL BACK IF THEY RECEIVED ANY ALERTS AND ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189810 ↗
• MalfunctionMar 14, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT WAS IN THERAPY ON THE ARCTIC SUN DEVICE (SERIAL (B)(6)) WHEN THE NURSE CAME ON FOR A SHIFT, AND THEY NOTICED THAT THE DEVICE WAS ALERTING LOW FLOW (ALERT 02) AND REDUCED WATER TEMPERATURE CONTROL (ALERT 113). THE PATIENT TEMPERATURE WAS 38.3C, TARGET TEMPERATURE WAS 37C, WATER TEMPERATURE WAS 26.2C AND FLOW RATE WAS 0.6LPM. WHILE LOOKING AT THE PATIENT MORE CLOSELY, IT WAS FOUND THAT THERE WERE ONLY TWO UNIVERSAL ARCTIC GEL PADS ON THE PATIENT'S CHEST OR ABDOMEN AREA. THE PATIENT WEIGHED 86 KILOGRAMS. THE SYSTEM HOURS WERE 5122, PUMP HOURS WERE 4651, MIXING PUMP COMMAND WAS 100 PERCENT AND CHILLER TEMPERATURE (T4) WAS 4C. THE NURSE FOUND ANOTHER ARCTIC SUN DEVICE (SERIAL (B)(6)) AND WAS GOING TO LOOK FOR A SET OF PADS AND WOULD CALL BACK IF THEY NEEDED ANY HELP SETTING UP THE NEW DEVICE. PER FOLLOW-UP INFORMATION RECEIVED ON 24FEB2022, THE NURSE STATED THAT THEY DID NOT USE A SECOND ARCTIC SUN DEVICE BECAUSE IT WAS DETERMINED THAT THE PATIENT HAD MET THE WARMING PERIOD AND NO LONGER REQUIRED THE ARCTIC SUN DEVICE. THE DEVICE WAS FLAGGED FOR BIOMED DUE TO ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) AND THAT THE DEVICE BELONGED TO A SISTER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758233 ↗
• MalfunctionJul 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE GEL SEPARATED FROM THE PAD. PATIENT HAD USED MEDIHONEY OINTMENT FOR AN ABRASION ON THE HIP.

  Patient problems: Abrasion

  MAUDE report 12135446 ↗
• MalfunctionApr 20, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THERE WERE FREQUENT LOW FLOW ALARMS ON ARCTIC SUN DEVICE WHEN ARCTIC GEL PADS WERE CONNECTED TO IT . CUSTOMER CALLED HELPLINE AND WAS INSTRUCTED ON PROPER CONNECTION OF PADS TO FLUID DELIVERY LINE. CUSTOMER STATED THAT PICTURE 7 ON OUTSIDE OF ARCTIC GEL PAD PACKAGING, INDICATED THE HANDS ON THE CLEAR PLASTIC CONNECTION AND THAT LEAD TO CONFUSION SINCE THE REFERENCE GUIDE INSTRUCTS NOT TO TOUCH THE CLEAR CONNECTOR WHEN PLACING TO FLUID DELIVERY LINE. PER FOLLOW UP WITH CUSTOMER ON 31MAR2021, CUSTOMER STATED THAT PATIENT COMPLETED THERAPY AND NURSE WAS UNSURE OF FLOW RATE. NURSE NOTED THAT THE EDUCATOR HAD SPOKEN TO THE NURSING STAFF REGARDING PROPER PAD CONNECTION AND THAT THE EDUCATOR HAD ALSO REACHED OUT FOR FURTHER TEACHING MATERIALS .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692934 ↗
• MalfunctionMar 9, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD BEEN ALARMING WITH FLOW RATE ISSUES. NURSE RECONNECTED THE PADS ON DIFFERENT PLACES ON THE MANIFOLD. PATIENT HAD REACHED THE TARGET TEMPERATURE AND THIS WAS STOPPING THERAPY. USER STATED THAT IF THE PATIENT NEEDED TO RECOMMENCE THERAPY, THEN A DIFFERENT SYSTEM WOULD BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447125 ↗