Arctic Sun® Temperature Management System, Fluid Delivery Lines 73407Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00801741080265), received between Feb 1, 2022 and Jan 28, 2026 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (38 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Nonstandard Device; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE GAVE AN ALARM RELATED TO AN OPEN LINE. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 16JAN2026, BIOMED TRYING TO PERFORM MAINTENANCE ON DEVICE. HAD BYPASS LOOPS IN PLACE AND KEEPS GETTING MESSAGE THAT THERE WAS AIR IN THE LINES. PER REVIEW OF WO NOTES THE DEVICE WAS NOT CONFIGURED CORRECTLY FOR TESTING, THEY WERE USING A SIMULATOR TO TEST WITH PADS CONNECTED. DURING FUNCTIONAL TESTING WITH TS THE DEVICE DISPLAYED ALARM 41. IT WAS THEN DETERMINED THAT THE DEVICE HAD A FAILED FLOW METER. CIRCULATION PUMP COMMAND (CPC) WAS 49%, INLET PRESSURE (IP) WAS -7.0, FLOW RATE (FR) WAS 0.0. SHUNT CONNECTED AND VERIFIED VISUAL FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206099 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT THE NURSE NOTED THAT THE ARCTIC SUN DEVICE WAS LEAKING WHERE THE PAD CONNECTS TO THE BIG GREY HOSE. THEY THINK THE MANIFOLD WAS CRACKED. THEY WERE NOT IN THE ROOM. EXPLAINED THIS MAY CAUSE FLOW RATE ISSUES, OR A TRIP HAZARD FOR THE FAMILY/HCPS IN THE ROOM. THEY CAN TRY ANOTHER PORT TO SEE IF THIS RESOLVES THIS ISSUE, BUT IF NOT, THEY MAY WANT TO GO AHEAD AND REPLACE THE DEVICE. HAD THEM GO TO THE ROOM TO CONFIRM FLOW RATE AND SN. DEVICE WAS FLOWING AT 2.7LPM. THEY WILL CALL FOR A NEW DEVICE. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 05JAN2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED A BIOMED HAD RECEIVED THE DEVICE. NO REPORTED ISSUES AFTER DEVICE SWAP. PROVIDED NUMBER FOR BIOMED. CALLED BIOMED WHO CONFIRMED FLUID DELIVERY LINE WAS CRACKED. STATED IT LOOKED LIKE IT HAD BEEN BENT FROM POOR STORAGE, LIKE THE NURSES BENT OR COILED IT TOO TIGHTLY. THEY DISPOSED OF THE FLUID DELIVERY LINE AND ORDERED A NEW ONE. IT HAS NOT ARRIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063338 ↗
• MalfunctionDec 11, 2025Nonstandard Device; Gas/Air Leak; Nonstandard Device; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE ARCTIC SUN DEVICE HAD A LOW PRESSURE DURING THE INSPECTION OF THE FLUID DELIVERY LINE. PER REVIEW OF WO NOTES IT WAS DETERMINED THAT THE FLUID DELIVERY LINE (FDL) WILL NEED NEW VALVES FOR ONE SET. CIRCULATION PUMP COMMAND (CPC) WAS 48%, INLET PRESSURE (IP) WAS -7.0, FLOW RATE (FR) WAS 1.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779765 ↗
• MalfunctionDec 11, 2025Nonstandard Device; Gas/Air Leak; Nonstandard Device; Gas/Air Leak

  IT WAS REPORTED THAT BIOMED LOOKING TO DETERMINE IF JUST VALVES OR COMPLETE FDL NEEDS TO BE REPLACED. WOULD LIKE TO GET PART NUMBERS FOR APPLICABLE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778272 ↗
• MalfunctionNov 8, 2025Nonstandard Device; Gas/Air Leak; Nonstandard Device; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS FAILING THE FLUID DELIVERY LINE (FDL) VALVE TEST, THE DEVICE HAS OVER 2000 HOURS AND NO HISTORY OF THE 2K PM. COMING IN FOR 2K PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23505260 ↗
• MalfunctionNov 4, 2025Restricted Flow rate; Nonstandard Device; Restricted Flow rate; Nonstandard Device

  IT WAS REPORTED THAT THE NURSE RECENTLY BEGAN THERAPY AND THE ARCTIC SUN DEVICE NOW ALERTING PATIENT LINE OPEN AND LOW FLOW. NURSE STATES HAD ALREADY DISCONNECTED AND RECONNECTED PADS INTO DIFFERENT MANIFOLDS AND CONFIRMED CONNECTIONS. TARGETED TEMPERATURE (TT) WAS 36C, PATIENT TEMPERATURE (PT) WAS 36.7C, WATER TEMPERATURE (WT) WAS 8.5C, WATER FLOW RATE (WFR) WAS 0 L/M. SYSTEM DIAGNOSTICS WITH PADS SHOWED THAT THE WATER FLOW RATE (WFR) WAS 0 L/M, INLET PRESSURE (IP) WAS -0.5PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 0, SYSTEM HOURS WERE 13,600 AND PUMP HOURS WERE 12,495.6. PLACED DEVICE IN MANUAL CONTROL AT 36C WITH NO PADS. SYSTEM DIAGNOSTICS SHOWED THAT THE WATER FLOW RATE (WFR) WAS 1.8 L/M, INLET PRESSURE (IP) WAS -6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0. DEVICE ALERTED 47 CONTROL PANEL COMMUNICATION, SO THEY REBOOTED DEVICE AND THE ALERT DID NOT RETURN. WALKED THROUGH DISABLING MANUAL CONTROL AND HAVE A COUPLE DEVICES. SUGGESTED TRYING THE PADS ON ANOTHER DEVICE AS THIS SEEMS TO BE A DEVICE ISSUE. IF THE NEW DEVICE WORKS, SEND THIS DEVICE TO BIOMED LABELLED LOW FLOW, PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471904 ↗
• MalfunctionOct 28, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THEY WERE GETTING A PATIENT LINE OPEN MESSAGE ON ARCTIC SUN DEVICE S/N (B)(6). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, PUMP HOURS WERE 3016.5, SYSTEM HOURS WERE 3174.8. STOPPED THERAPY. EMPTIED AND DISCONNECTED THE PADS. PLACED DEVICE IN MANUAL MODE. INLET PRESSURE (IP) REMAINED AROUND -2PSI. ADVISED TO SEND DEVICE TO BIOMED AND CHANGE TO ANOTHER DEVICE. ON A FOLLOW-UP CALL NURSE STATED THEY COULD SEE A HOLE IN THE FLUID DELIVERY LINE. IT WAS REPORTED THAT THEY CHANGED TO ARCTIC SUN DEVICE S/N (B)(6), BUT NOW THEY WERE HAVING A DIFFERENT PROBLEM. THE DEVICE WILL NOT FILL. WATER LEVEL WITH ONE BAR. FLUID DELIVER LINE ATTACHED WITH NOTHING ATTACHED TO FLUID DELIVERY LINE. HAD NURSE REMOVE THE FLUID DELIVERY LINE AND PLUG THE PORTS ON THE BACK OF THE MACHINE TO SEE IF THEY COULD FEEL SUCTION. RESERVOIR FILLED WHEN SHE PLUGGED THE PORTS. CONNECTED PADS AND TRIED TO START THERAPY. FLOW RATE WAS 0LPM, INLET PRESSURE WAS -0PSI, CIRCULATION PUMP COMMAND WAS 100%. PUMP HOURS 5071.5, SYSTEM HOURS 5317.2. STOPPED THERAPY. DISCONNECTED PADS AND STARTED MANUAL MODE. INLET PRESSURE AND FLOW REMAINED AT 0. EXPLAINED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404133 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THEY WERE GETTING A PATIENT LINE OPEN MESSAGE ON ARCTIC SUN DEVICE S/N (B)(6). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, PUMP HOURS WERE 3016.5, SYSTEM HOURS WERE 3174.8. STOPPED THERAPY. EMPTIED AND DISCONNECTED THE PADS. PLACED DEVICE IN MANUAL MODE. INLET PRESSURE (IP) REMAINED AROUND -2PSI. ADVISED TO SEND DEVICE TO BIOMED AND CHANGE TO ANOTHER DEVICE. ON A FOLLOW-UP CALL NURSE STATED THEY COULD SEE A HOLE IN THE FLUID DELIVERY LINE. IT WAS REPORTED THAT THEY CHANGED TO ARCTIC SUN DEVICE S/N (B)(6), BUT NOW THEY WERE HAVING A DIFFERENT PROBLEM. THE DEVICE WILL NOT FILL. WATER LEVEL WITH ONE BAR. FLUID DELIVER LINE ATTACHED WITH NOTHING ATTACHED TO FLUID DELIVERY LINE. HAD NURSE REMOVE THE FLUID DELIVERY LINE AND PLUG THE PORTS ON THE BACK OF THE MACHINE TO SEE IF THEY COULD FEEL SUCTION. RESERVOIR FILLED WHEN SHE PLUGGED THE PORTS. CONNECTED PADS AND TRIED TO START THERAPY. FLOW RATE WAS 0LPM, INLET PRESSURE WAS -0PSI, CIRCULATION PUMP COMMAND WAS 100%. PUMP HOURS 5071.5, SYSTEM HOURS 5317.2. STOPPED THERAPY. DISCONNECTED PADS AND STARTED MANUAL MODE. INLET PRESSURE AND FLOW REMAINED AT 0. EXPLAINED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404101 ↗
• MalfunctionOct 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE WATER TEMPERATURE WAS NOT REACHING TARGET DUE TO AIR LEAK AT FLUID DELIVERY LINE CONNECTOR TEMPERATURE PROBE SHOWING INTERMITTENT CONNECTION IN AN ARCTIC SUN DEVICE. TESTS SHOWED THE DELIVERY HOSE WAS LEAKING AIR INTO THE SYSTEM THROUGH ONE OF THE CONNECTORS. ADDITIONALLY, THE TEMPERATURE PROBE WAS GIVING INTERMITTENT READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337511 ↗
• MalfunctionSep 25, 2025Nonstandard Device; Gas/Air Leak; Nonstandard Device; Gas/Air Leak

  IT WAS REPORTED THAT THE DURING VISUAL INSPECTION, THERE WAS NO DAMAGE. IN TEST AND FUNCTIONALITY CHECK PERFORMED SEVERAL TIMES. THE PSI VALUE FLUCTUATES TOO MUCH IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 23SEP2025, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145089 ↗
• MalfunctionAug 11, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE NURSE NOTED THEY WERE TRYING TO FILL THE ARCTIC SUN DEVICE, AND TASK APPEARS TO BE "STUCK." ASKED IF THEY EMPTIED PADS FIRST AND THEY STATE THEY DID NOT. HAD THEM STOP FILLING RESERVOIR AND EMPTIED PADS. WATER RESERVOIR LEVEL SHOWS 3 AT THIS TIME. WHEN ATTEMPTING TO FILL DEVICE IT APPEARS TO BE "STUCK" AGAIN (THE SCREEN SAYS FILLING, BUT NO WATER MOVING INTO PADS AND MESSAGE NEVER DISAPPEARED FROM SCREEN). STOPPED TASK AGAIN AND RESTARTED THERAPY. FLOW RATE (FR) WAS 2LPM. SUGGESTED HAVING BIOMED CHECK THIS ISSUE AFTER THERAPY WAS COMPLETE. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 07AUG2025, TRANSFERRED TO FLOOR DIRECTOR WHO CONFIRMED THIS DEVICE HAD BEEN TRANSPORTED TO THE BIOMED THREE WEEKS AGO. THEY DID NOT HAVE ANY PATIENT INFORMATION TO SHARE AND NOTED THEY WERE NOT FAMILIAR WITH THE ORIGINAL COMPLAINANT. THEY TOOK THE INFORMATION TO DISCUSS WITH THE CHARGE NURSE ONCE THEY WERE AVAILABLE. TRANSFERRED TO THE BIOMED. SPOKE WITH BIOMED WHO CONFIRMED ORDERING A NEW CIRCULATION PUMP FOR THIS DEVICE. THEY ALSO NOTED A CLOG IN THE FLUID DELIVERY LINE (FDL). THE BIOMED COMPLETED A TOTAL DRAIN AND CLEANING OF THE DEVICE. AFTER PUMP INSTALLATION, DEVICE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772212 ↗
• MalfunctionJun 19, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE PATIENT TEMPERATURE MONITOR VALUE FLUCTUATED DURING NORMOTHERMIA IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 22NOV2024, DEVICE WAS USED ON PATIENT AND THERE WAS NO PATIENT INJURY REPORT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 22NOV2024, THE DEVICE WOULD BE SENT TO IMI. THE ISSUE HAS NOT BEEN RESOLVED YET. THERAPY COMPLETION STATUS WAS UNDER INVESTIGATION. THERE WAS NO IMPACT TO THE PATIENT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 05MAY2025, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE FLUID DELIVERY LINE (FDL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292153 ↗
• MalfunctionJun 16, 2025Restricted Flow rate; Defective Component; Restricted Flow rate; Defective Component

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE ARCTIC SUN DEVICE NOW WOULD NOT FILL. PER REVIEW OF WO, IT WAS DETERMINED THAT THE DEVICE HAD AN AIR LEAK SOMEWHERE IN THE FLUID DELIVERY LINE. PARTS AND PRICE PROVIDED FOR A NEW FLUID DELIVERY LINE (FDL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212832 ↗
• MalfunctionJun 6, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE NURSE STATED THAT THE HOSE ON THE BACK OF THE ARCTIC SUN DEVICE THE GEL PADS CONNECT TO WAS MISSING. THIS WAS THE FLUID DELIVERY LINE, AND THE PART NUMBER WAS 73407.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157612 ↗
• MalfunctionMay 27, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE DURING PREVENTIVE MAINTENANCE THERE WAS A CIRCULATION PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090259 ↗
• MalfunctionMay 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS NOT PASSING THE FLUID DELIVERY LINE TEST. INLET PRESSURE (IP) WAS -2.4 PSI. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 12MAY2025, BIOMED DOING MAINTENANCE CHECK ON DEVICE. CHECKING FLUID DELIVERY LINE (FDL). PLACED DEVICE IN MANUAL CONTROL AT 28 C FOR 30 MINUTES, BUT PSI ONLY AT 2.4 INSTEAD OF 7 LISTED IN THE MANUAL. TRANSFERRED FOR ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036274 ↗
• MalfunctionApr 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE THAT THE ARCTIC SUN DEVICE BRINGS LEAKAGE ERROR. PER REVIEW OF WO ON 29APR2025, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 29APR2025, DEVICE WOULD BE REPAIRED IN THE HOSPITAL BY CRS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935062 ↗
• MalfunctionApr 17, 2025Restricted Flow rate; Defective Component; Restricted Flow rate; Defective Component

  IT WAS REPORTED THAT THE NURSE STATED THAT THEY WERE TRYING TO START THERAPY ON A PATIENT. THE ARCTIC SUN DEVICE WAS ALARMING THE RESERVOIR WAS EMPTY. THEY WERE TRYING TO FILL THE DEVICE, BUT IT WAS NOT TAKING UP ANY WATER. CONFIRMED FILL TUBE WAS CONNECTED TO THE CORRECT FILL PORT. NURSE STATED THAT THE PADS ARE CONNECTED, THEY HAD TRIED IT WITH AND WITHOUT THE PADS CONNECTED. HAD NURSE DISCONNECT THE PADS AND TRY FILLING RESERVOIR. DEVICE STILL NOT TAKING UP WATER, NURSE COULD NOT HEAR THE DEVICE RUNNING LIKE IT WAS TRYING TO FILL. HAD NURSE TRY REMOVING THE FLUID DELIVERY LINE (FDL) TO SEE IF THEY WERE ABLE TO FEEL THE SUCTION, BUT NURSE UNABLE TO GET FLUID DELIVERY LINE (FDL) OFF. INFORMED NURSE TO SEND THIS DEVICE TO BIOMED FOR EVALUATION AND SWITCH TO ANOTHER DEVICE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 28MAY2025, SPOKE WITH BIOMED WHO CONFIRMED THEY REPLACED THE FDL, AND THE DEVICE WORKED WITHOUT ISSUE. THEY DID NOT INSPECT IT, BUT THERE MIGHT HAVE BEEN A MINOR HOLE IN THE TUBE CAUSING AIR TO ENTER. THE FDL HAD BEEN DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858879 ↗
• MalfunctionApr 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NURSE WAS WALKING BY THEIR ARCTIC SUN MACHINE AND NOTICED THE FLUID DELIVERY LINE (FDL) WAS RIPPED IN HALF. NURSE ASKED HOW TO GO ABOUT REPLACING IT. INFORMED NURSE THEY COULD ORDER A REPLACEMENT FLUID DELIVERY LINE (FDL) FOR THE DEVICE. SUGGESTED WHOEVER ORDERS THEIR SUPPLIES, SUCH AS MATERIALS MANAGEMENT. OR SUGGESTED SENDING IT TO BIOMED AND HAVING THEM ORDER A REPLACEMENT. NURSE WOULD PUT IN A WORK ORDER FOR BIOMED TO REPLACE THE FLUID DELIVERY LINE (FDL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856937 ↗
• MalfunctionMar 31, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO START THERAPY, BUT THE ARCTIC SUN DEVICE WAS ALERTING PATIENT LINE OPEN. SN #(B)(6). HAD NURSE EMPTY PADS AND DISCONNECT (NEW SMALL PADS). FLUID DELIVERY LINE (FDL) SECURE AND IN LOCK POSITION. RECONNECTED HOLDING NOWHERE NEAR CLEAR CONNECTORS AND VERIFIED AUDIBLE CLICKS WITH EACH CONNECTION. STRAIGHTENED ALL LINES. RESTARTED THERAPY. WATER FLOW RATE (WFR) GOT UP TO 0.6L/M THEN DROPPED BACK TO 0 AND DEVICE STOPPED. CONFIRMED ALERTS 01 & 02, SYSTEM HOURS WERE 5465, PUMP HOURS WERE 4889. PLACED DEVICE IN MANUAL CONTROL, INLET PRESSURE (IP) WAS -1.0, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE MIXING PUMP COMMAND (MPC) WAS 0, FLOW RATE (FR) WAS 1.1L/M. DISABLED MANUAL CONTROL AND HAD RN TRY ONE MORE TIME TO START THERAPY. INLET PRESSURE (IP) WAS -0.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0 (FR JUMPED TO 1.3 FOR ONLY A MINUTE AND DROPPED BACK TO 0). EXPLAINED THIS DEVICE NEEDS TO GO TO BIOMED. CONFIRMED THEY DO NOT HAVE ANOTHER DEVICE AND WILL HAVE TO FIND ANOTHER SOURCE TO WARM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730667 ↗
• MalfunctionMar 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED DOING A 6-MONTH PREVENTIVE MAINTENANCE AND ONE SET OF FLUID DELIVERY LINE (FDL) VALVES WERE NOT MAINTAINING -7 PSI, IT REACHED -5.0, ALL OTHER VALVES ARE MAINTAINING -7.0 IN AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539816 ↗
• MalfunctionFeb 26, 2025Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED STATED THE USER SENT THE ARCTIC SUN DEVICE DOWN TO BIOMED BECAUSE HALF OF THE FLUID DELIVERY LINE WAS NOT MAINTAINING INLET PRESSURE. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 03APR2025, SPOKE WITH BIOMED, WHO STATED THE FLUID DELIVERY LINE (FDL) WAS FOUND TO BE FAULTY. FLUID DELIVERY LINE (FDL) WAS DISPOSED OF AND NEW ONE HAD BEEN ORDERED. DEVICE HAS BEEN RETURNED TO SERVICE. THEY WERE UNSURE WHAT UNIT THE DEVICE WAS ORIGINALLY SENT FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469829 ↗
• MalfunctionFeb 4, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE NURSE STATED THAT THE FLUID DELIVERY LINE (FDL) WAS IMPROPERLY LATCHED INTO PLACE ON THE BACK OF THE ARCTIC SUN DEVICE AND WAS UNABLE TO START THERAPY. MULTIPLE NURSES HAVE TRIED TO SLIDE THE SILVER LEVER TO LOOSEN THE FLUID DELIVERY LINE (FDL), BUT IT WOULD NOT MOVE. CONFIRMED THE LEVEL SHOULD SLIDE HORIZONTALLY. SUGGESTED HAVING BIOMED COME LOOK AT THE DEVICE WHEN THEY WERE IN HOUSE LATER. NO OTHER DEVICES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309569 ↗
• MalfunctionJan 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED DID PREVENTIVE MAINTENANCE CHECK ON THEIR ARCTIC SUN DEVICE. WHEN THEY CHECKED EACH VALVE ON THE FLUID DELIVERY LINE (FDL), ONLY ONE WAS WITHIN SPECIFICATION WITH A PSI OF -7. THE OTHER VALVES ARE GIVING A PSI OF ABOUT -5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223146 ↗
• MalfunctionJan 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED HAD THE ARCTIC SUN DEVICE THAT THEY WERE DOING THE 6-MONTH PREVENTIVE MAINTENANCE ON AND THE FLOW RATE (FR) TEST WAS NOT PASSING, 5 OF THE 6 SETS OF VALVES WERE GETTING INLET PRESSURE (IP) OF -5.0, HAD THE BIOMED CYCLE ALL THE VALVES OPEN AND SHUT TO ENSURE THEY WERE FULLY CLOSED AND THAT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219494 ↗