Arctic Sun® 5000 50000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,903 adverse event reports that list this exact device (DI 00801741080142), received between Mar 19, 2018 and Sep 28, 2026 — classified as 3 deaths, 396 injuries, 6,504 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (1,268 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 27, 2024Open, Classified

   If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

   Z-2457-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,903 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916262 ↗
• MalfunctionSep 23, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873291 ↗
• MalfunctionSep 17, 2026Failure to Pump; Calibration Problem

  It was reported biomed stated that Arctic Sun device was failed calibration error 1.Per WO notes circulation pump was failing (CPC- 66 percentage).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802950 ↗
• MalfunctionJul 30, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084497 ↗
• InjuryJul 14, 2026Patient Device Interaction Problem

  It was reported Critical care nurses reported in an online survey that a nurse stated that an adverse event was experienced as a result of the chair session, this being: "Fever has gone down" while using "Arctic Sun 5000" with pads "Medium (M)". Additionally, a nurse stated that the patient experienced other associated adverse events: Electrolyte Disturbance (e.g. Hypokalemia, hyperkalemia), and the medical intervention was: " Substitute irrigation". While using "Arctic Sun 5000" with pads "Medium (M)". A01 Reaction against device 5000. Additionally, a nurse stated that an adverse event was experienced as a result of the chair session, this being: "Fever has gone down " while using "Arctic Sun 5000" with pads "Large (L)". Additionally, a nurse stated that the patient experienced other associated adverse events: Electrolyte Disturbance (e.g. hypokalemia, hyperkalemia), and the medical intervention was: "Substitute irrigation". While using "Arctic Sun 5000" with pads "Large (L)". A01 Reaction against device 5000. Additionally, a nurse stated that the patient experienced other associated adverse events: Electrolyte Disturbance (e.g. hypokalemia, hyperkalemia), and the medical interven

  Patient problems: Electrolyte Imbalance; Insufficient Information

  MAUDE report 25820137 ↗
• MalfunctionJun 4, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT COOLING. CHILLER TEMPERATURE (T4) WAS AT 4C, OUTLET CONTROL TEMPERATURE (T2) WAS 31C, MIXING PUMP COMMAND (MPC) WAS AT 100 PERCENTAGE. PER WO NOTES, THEY DISCUSSED THIS WAS INDICATIVE OF A FAILED MIXING PUMP AND REQUESTED A QUOTE FOR A DEPOT REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399148 ↗
• MalfunctionJun 3, 2026Restricted Flow rate

  IT WAS REPORTED THAT THEY WERE GETTING ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) IN AN ARCTIC SUN DEVICE. THERE ARE EXTRA HOLES ON THE FLUID DELIVERY LINE (FDL) THEY WERE NOT USING AND WAS NOT SURE IF THAT IS WHAT WAS CAUSING IT OR NOT. FLOW WAS 0LPM, INLET PRESSURE (IP) WAS -0.5PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, PUMP HOURS WERE 1116.9 AND SYSTEM HOURS WERE 1249. HAD NURSE DISCONNECT AND RECONNECT THE PADS USING PROPER TECHNIQUE. DEVICE SOUNDED ALERT 113 (REDUCED WATER TEMPERATURE CONTROL). TARGET TEMPERATURE WAS 37C, PATIENT TEMPERATURE WAS 42.5C, WATER TEMPERATURE WAS 20.6C, CHILLER TEMPERATURE (T4) WAS 5.6C, MIXING PUMP COMMAND WAS 0 PERCENTAGE, BUT WHEN HAD CHECK FLOW RATE, IT WAS 0LPM, INLET PRESSURE (IP) WAS -0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE. ASKED NURSE TO PRESS STOP, AND START THERAPY AGAIN, BUT THE SCREEN WOULD NOT RECOGNIZE TOUCH. ASKED NURSE TO SEND DEVICE TO BIOMED FOR INSPECTION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 26MAY2026, BIOMED DENIED RECEIVING THIS DEVICE AND SUGGESTED IT MIGHT STILL BE ON THE UNIT. PROVIDED NURSE CONTACT AND UNIT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386043 ↗
• MalfunctionMay 28, 2026Nonstandard Device

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE ARCTIC SUN DEVICE WAS NOT HEATING PROPERLY. PER REVIEW OF WO NOTES, WHEN THE DEVICE WAS POWERED ON THE DEVICE ALERTED THAT IT WAS EMPTY, THEY STATED THAT THEY HAD TO CALL BACK SO THAT THEY COULD GO AND LOCATE THE ITEMS NEEDED TO DRAIN AND FILL. CALLED BACK AND REQUESTED A QUOTE FOR ASSESSMENT STATING THAT THEY FILLED IT BUT DID NOT HAVE TIME TO DO THE TESTING TO TS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324523 ↗
• MalfunctionMay 22, 2026Restricted Flow rate

  IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY USING ARCTIC SUN DEVICE S/N: (B)(6) BUT WERE GETTING ALERT 01 (PATIENT LINE OPEN) AND 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, PUMP HOURS WERE 9111.6, SYSTEM HOURS WERE 9808.9, TARGETED TEMPERATURE (TT) WAS 36C. HAD NURSE STOP THERAPY, EMPTY AND DISCONNECT THE PADS. ENABLED MANUAL MODE. IN MANUAL MODE FLOW AND INLET PRESSURE (IP) REMAINED 0 AND CIRCULATION PUMP COMMAND (CPC) WAS 100%. ADVISED NURSE TO SEND DEVICE TO BIOMED FOR REPAIR. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 18MAY2026, TRANSFERRED TO THE BIOMED. SPOKE WITH RECEPTIONIST WHO DID NOT HAVE INFORMATION ON THIS DEVICE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262624 ↗
• MalfunctionMay 22, 2026Nonstandard Device; Calibration Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT COOLING WITH A CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE). EXPECTED VALUE WAS 6, ACTUAL VALUE WAS 31C. CHILLER TEMPERATURE (T4) WAS READING 31C. PER WO NOTES, THEY HAD DRAIN OFF THE CHILLER TANK AND APPROXIMATELY 500 ML CAME OUT AND DISCUSSED THAT THIS WAS INDICATIVE OF A CHILLER FAILURE. THEY STATED THE ACCOUNT INFORMATION WAS INCORRECT, SO WOULD GENERATE A QUOTE FOR DEPOT REPAIR ONCE THE ACCOUNT INFORMATION WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262604 ↗
• MalfunctionMay 22, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO START THERAPY AND WAS GETTING NO FLOW IN AN ARCTIC SUN DEVICE. DISCONNECTED AND RECONNECTED PADS USING PROPER TECHNIQUE. THEY THEN GOT A PROBE OUT OF RANGE THAT SEEMED TO BE RESOLVED RESEATING THE PROBE. STARTED THERAPY AND GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 13,768, PUMP HOURS WERE 11,917, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0LPM AND WOULD GET A NEW DEVICE AND SEND THIS ONE TO BIOMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260782 ↗
• MalfunctionMay 21, 2026Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS HAVING LOW FLOW ALARMS AND THEY WERE UNABLE TO FILL. PER WO NOTES, DURING THE FUNCTIONAL VERIFICATION, THE INLET PRESSURE WAS -1.0 PSI EVEN WITH A CIRCULATION PUMP COMMAND (CPC) WAS OF 100 PERCENTAGE AND FLOW RATE WAS 0 LPM. THEY DISCUSSED THIS WAS INDICATIVE OF A FAILED CIRCULATION PUMP. THEY DISCUSSED THE 2000 HOUR SERVICE AND DISCUSSED THAT THIS DEVICE WAS NEAR END OF SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242069 ↗
• MalfunctionMay 16, 2026Nonstandard Device

  IT WAS REPORTED THAT BEFORE SOFTWARE UPDATE, AT FLOW RATE TEST, THE VALUE WAS OUT OF ALLOWANCE NEGATIVE 392 ML MIN IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 06FEB2026, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196025 ↗
• MalfunctionMay 15, 2026Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE BIOMED NEEDS ASSISTANCE WITH THE ARCTIC SUN DEVICE WHERE PATIENT TEMPERATURE (PT) 2 PROBE WAS NOT REGISTERING. VERIFIED PATIENT TEMPERATURE (PT) 2 WAS ENABLED. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 12MAY2026, THE ISSUE WAS A BAD CORD. THEY REPLACED THE CORD WITH A SPARE ONE THAT THEY HAD, AND THAT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185817 ↗
• MalfunctionMay 15, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY TRYING TO INITIATE THERAPY ON PATIENT WITH NEW SET OF PADS. ARCTIC SUN DEVICE KEEPS ALERTING 02 LOW FLOW. NURSE STATED THEY'VE ALREADY TRIED DISCONNECTING AND RECONNECTING WITH NO RESOLUTION. PATIENT TEMPERATURE (PT) WAS 38.3C, TARGETED TEMPERATURE (TT) WAS 35C. WALKED THROUGH STOP THERAPY AND DISCONNECT PADS. PLACED DEVICE IN MANUAL CONTROL AT 10C WITH NO PADS CONNECTED. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE (T1) WAS 10.2C, OUTLET CONTROL TEMPERATURE (T2) WAS 10.2C, INLET TEMPERATURE (T3) WAS 10.6C, CHILLER TEMPERATURE (T4) WAS 4.6C, WATER FLOW RATE (WFR) WAS 2.3 LM, INLET PRESSURE (IP) WAS -7.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 89 PERCENT, MIXING PUMP COMMAND (MPC) WAS 18 PERCENT, HEATER COMMAND (HC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 30800.8, PUMP HOURS WERE 12504.9. RECONNECTED PADS WHILE STILL IN MC AND WATER FLOW RATE (WFR) WAS 0.8 LM, INLET PRESSURE (IP) WAS -0.5PSI. DISABLED MANUAL CONTROL AND RESTARTED THERAPY WITH PADS CONNECTED. WATER FLOW RATE (WFR) WAS 0 LM AND DEVICE LOW AIR LEAK. ADVISED SWAPPING OUT TO ALTERNATE DEVICE. SEND THIS ONE TO BIOMED LABELED LOW FLOW. SN (B)(6). PER FOLLOW UP INFORMATION RECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185809 ↗
• MalfunctionMay 9, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE NURSE NEEDS HELP TROUBLESHOOTING AN ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) IN AN ARCTIC SUN DEVICE. PATIENT TEMPERATURE (PT) WAS 38.5C, TARGETED TEMPERATURE (TT) WAS 36.7C, WATER TEMPERATURE (WT) WAS 23.7C, FLOW RATE (FR) WAS 1.3LPM. GUIDED TO DIAGNOSTICS: SYSTEM HOURS 3327, PUMP HOURS 2495, CHILLER TEMPERATURE (T4) WAS 4.2C, MIXING PUMP COMMAND (MPC) WAS 100 PERCENT. ADVISED THIS DEVICE SHOULD GO TO BIOMED SO THEY CAN CALL AND TROUBLESHOOT WITH BD TECH SUPPORT ON MONDAY. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 05MAY2026, SPOKE WITH BIOMED WHO CONFIRMED A BAD MIXING PUMP WOULD BE REPLACED ONSITE. THEY HAVE NOT ORDERED THE PART AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25132855 ↗
• MalfunctionMay 6, 2026Nonstandard Device; Calibration Problem

  IT WAS REPORTED THAT THE BIOMED PERFORMING CALIBRATION IN AN ARCTIC SUN DEVICE. RECEIVED CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE), EXPECTED VALUE WAS 28 AND ACTUAL VALUE WAS 18.03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25106768 ↗
• MalfunctionMay 6, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO START THERAPY, BUT THE ARCTIC SUN DEVICE PRIMES AND STOPS. DISCONNECTED AND RECONNECTED USING PROPER TECHNIQUE. DEVICE PRIMED AND IMMEDIATELY STOPPED. GUIDED TO DIAGNOSTICS: SYSTEM HOURS 13,787, PUMP HOURS 12,497, INLET PRESSURE (IP) WAS -0.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, FLOW RATE (FR) WAS 0 LPM. MOVED PADS/PROBE TO A DIFFERENT AS ((B)(6)). FLOW RATE (FR) WAS SETTLED AT 1.4 LPM; SMALL PADS IN PLACE. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 30APR2026, TRANSFERRED TO THE BIOMED. SPOKE WITH BIOMED WHO STATED THEY HAD THIS DEVICE IN THEIR SHOP A WEEK OR TWO AGO. THEY DID NOT REPAIR THE DEVICE BECAUSE THE PART HAD NOT COME IN TIME AND THE NURSES WERE REQUESTING THE DEVICE BACK. THEY WOULD LOOK INTO GETTING A PM COMPLETED. NO REPAIRS MADE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105260 ↗
• MalfunctionMay 4, 2026Failure to Pump

  IT WAS REPORTED THAT WHEN ATTEMPTING TO REPLACE THE CIRCULATION WATER, THE ARCTIC SUN DEVICE DID NOT BEGIN SUCTION. AFTER LEAVING IT FOR ABOUT 2¿3 MINUTES, SUCTION STARTED. ONCE SUCTION WAS COMPLETED AND THE TANK WATER LEVEL REACHED ¿5,¿ THE DEVICE WAS OPERATED IN MANUAL MODE AT 25°C FOR 20 MINUTES, 4°C FOR 10 MINUTES, AND 40°C FOR 20 MINUTES. DURING THIS OPERATION, THE SUCTION PRESSURE WAS ¿6.9 PSI, AND THE FLOW RATE EXCEEDED 3 L/MIN. AFTER STOPPING THE DEVICE ONCE AND OPERATING IT AGAIN IN MANUAL MODE, THE NEGATIVE PRESSURE DROPPED TO ¿0.1 PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074166 ↗
• MalfunctionMay 1, 2026Insufficient Cooling; Nonstandard Device

  IT WAS REPORTED THAT THEY WERE TRYING TO DELIVER THERAPY USING S/N (B)(6), BUT THE ARCTIC SUN DEVICE WAS STOPPING, GIVING ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) (PR# (B)(6)). TARGETED TEMPERATURE (TT) WAS 36C, PATIENT TEMPERATURE (PT) WAS 36.1C, FLOW RATE (FR) WAS 3.2LPM, WATER TEMPERATURE (WT) WAS 31.5C, CHILLER TEMPERATURE (T4) WAS 3.8C, MIXING PUMP COMMAND (MPC) WAS 100%, SYSTEM HOURS 11000, PUMP HOURS 10063. EXPLAINED DEVICE NEEDS TO GO TO BIOMED LABELED WITH ALERT 113, NOT COOLING. THEY INITIALLY TRIED TO USE S/N (B)(6) BUT WAS GETTING LOW AIR LEAK. POWERED S/N (B)(6) BACK ON AND PRESSED CONTINUE CURRENT PATIENT. ENABLED MANUAL MODE. FLOW RATE (FR) WAS 1.7LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 62%, PUMP HOURS WERE 3487, SYSTEM HOURS 3883. CONNECTED PADS USING PROPER TECHNIQUE (PR# (B)(6)). FLOW RATE (FR) WAS 3.2LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 97%. DISABLED MANUAL MODE AND STARTED THERAPY. FLOW RATE (FR) WAS 3LPM, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 91%. THERAPY CONTINUED. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON (B)(6) 2026, SPOKE WITH NURSE WHO CONFIRMED NO F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060285 ↗
• MalfunctionApr 30, 2026Insufficient Heating

  IT WAS REPORTED THAT THE NURSE NOTES PATIENT TEMPERATURE (PT) HAD DROPPED AND WATER TEMPERATURE (WT) WAS NOT INCREASING IN RESPONSE IN AN ARCTIC SUN DEVICE. DENIES ANY ALERTS OR ALARMS. PATIENT HAS BEEN REWARMING SINCE 4:30PM. PATIENT TEMPERATURE (PT) WAS 33.8C, TARGETED TEMPERATURE (TT) WAS 37C, WATER TEMPERATURE (WT) WAS 23C, WATER FLOW RATE (WFR) WAS 2 L/M. 3 PADS CONNECTED TO ADULT PATIENT. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE (T1) WAS 22.8C, OUTLET CONTROL TEMPERATURE (T2) WAS 22.6C, INLET TEMPERATURE (T3) WAS 23.4C, CHILLER TEMPERATURE (T4) WAS 4.1C, WATER FLOW RATE (WFR) WAS 2 L PER M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 51 PERCENT, MIXING PUMP COMMAND (MPC) WAS18 PERCENT, HEATER COMMAND (HC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 2932.2, PUMP HOURS WERE 2365.1. NURSE CONFIRMS PATIENT WAS NOT SHIVERING, MICRO SHIVERING OR SEIZING. WALKED THROUGH STOP THERAPY AND EMPTY PADS. DRAINED 16 OUNCES OF WATER FROM RIGHT DRAIN PORT. ADVISED WILL CALL BACK IN 30 MINUTES TO CHECK IN ON WATER TEMPERATURE (WT). CALLED 3 TIMES WITH NO ANSWER. SN 1830. NURSE CALLED BACK BECAUSE PATIENT TEMPERATURE (PT) WAS STILL NOT INCREASING AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045487 ↗
• MalfunctionApr 30, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE LEFT MESSAGE WITH DESK FOR NURSE TO CALL BACK AT SINCE THEY COULD NOT COME TO THE PHONE. NURSE NOTED THEY HAVE RECEIVED MULTIPLE ALERTS, AND THE ARCTIC SUN DEVICE DID NOT SEEM TO BE REGULATING THE PATIENT TEMPERATURE (PT). EVENT LOG SHOWS MULTIPLE ALERT 113 REDUCED WATER TEMPERATURE CONTROL. PATIENT TEMPERATURE (PT) WAS 34.3C, TARGETED TEMPERATURE (TT) WAS 33.5C, WATER TEMPERATURE (WT) WAS 26.9C, WATER FLOW RATE (WFR) WAS 1.2 L PER M. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 27C, OUTLET CONTROL TEMPERATURE (T2) WAS 26.9C, INLET TEMPERATURE (T3) WAS 26.8C, CHILLER TEMPERATURE (T4) WAS 4.3C, WATER FLOW RATE (WFR) WAS 1.2 L PER M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 49 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 100 PERCENTAGE, HEATER WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 3730.4 AND PUMP HOURS WERE 3148.5. ADVISED SWAPPING OUT TO ALTERNATE DEVICE AND SENDING THIS ONE TO BIOMED LABELED 113 NOT COOLING. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 28APR2026, SPOKE WITH BIOMED WHO CONFIRMED A FAULTY MIXING PUMP. THEY WOULD BE ORDERING ONE THIS WEEK TO REPAIR ONSITE. NO FURTHER INFO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045486 ↗
• MalfunctionApr 29, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE IQVIA TECHNICIAN WAS ONSITE TO EXECUTE THE FIELD ACTION, BUT THIS ARCTIC SUN DEVICE WAS NOT COOLING CHILLER TEMPERATURE (T4) WAS 5.5C, OUTLET CONTROL TEMPERATURE (T2) WAS 30.9C, MIXING PUMP COMMAND (MPC) WAS AT 100 PERCENTAGE. PER WO NOTES, THEY DISCUSSED THIS WAS INDICATIVE OF A FAILED MIXING PUMP AND WOULD PROVIDE A DEPOT REPAIR QUOTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037947 ↗
• MalfunctionApr 29, 2026Circuit Failure

  IT WAS REPORTED THAT THE IQVIA TECH STATED THAT WHEN HE POWERED THE DEVICE ON THE DEVICE DISPLAYED ALARM 77. WO NOTES - FAILED CHILLER TANK THERMISTOR. T4: 99.9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037737 ↗
• MalfunctionApr 29, 2026Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT THEY SPOKE WITH BEDSIDE NURSE. THEY WERE TRYING TO DELIVER THERAPY ON A 103.5F PATIENT USING A ARCTIC SUN DEVICE THEY BORROWED FROM BETHLEHEM CAMPUS BUT WERE NOT GETTING FLOW. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0, CIRCULATION PUMP COMMAND (CPC) WAS 100%, PUMP HOURS 1851, SYSTEM HOURS 1973. STOPPED THERAPY AND DISCONNECTED PADS. ENABLED MANUAL MODE. FOW RATE (FR) WAS 0, INLET PRESSURE (IP) WAS 0, CIRCULATION PUMP COMMAND (CPC) WAS 100%. EXPLAINED DEVICE NEEDS TO GO TO BIOMED FOR A REPAIR. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 27APR2026, SPOKE WITH BIOMED WHO CONFIRMED A FAULTY CIRCULATION PUMP WOULD BE REPAIRED ONSITE. NO REPAIRS MADE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037681 ↗