ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) IC-3893Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00849111075084), received between Feb 25, 2016 and Mar 7, 2025 — classified as 1 death, 7 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (72 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM TREATMENT, THE REGISTERED NURSE (RN) FOUND THAT THE SALINE BAG ATTACHED TO THE ICY CATHETER (LOT #204218) WAS EMPTY. NO SALINE WAS ON THE FLOOR OR IN THE BED, SO THE CUSTOMER ASSUMED SOME SALINE MIGHT HAVE INFUSED INTO THE PATIENT'S BODY. A POSSIBLE CATHETER LEAK WAS SUSPECTED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21554318 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE ICY CATHETER (LOT# 196374) WAS PLACED IN THE LEFT FEMORAL VEIN SMOOTHLY AFTER THE FIRST ATTEMPT. AFTER LESS THAN AN HOUR, THE CUSTOMER OBSERVED THE SALINE BAG NEARLY EMPTIED. NO SALINE LEAK WAS OBSERVED ON THE THERMOGARD CONSOLE, PATIENT BED, OR FLOOR. NO BLOOD WAS NOTED IN THE TUBING. THE CUSTOMER WAS ASKED TO REMOVE THE CATHETER DUE TO A SUSPECTED LEAK AND THE INFUSION OF APPROXIMATELY 200 ML OF SALINE FLUID. THE CUSTOMER FOLLOWED THE INSTRUCTIONS OF THE ZOLL TECH SUPPORT PERSON AND HAD THE ICY CATHETER REMOVED WITHOUT TESTING. A NEW ICY CATHETER WAS PLACED TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924919 ↗
• MalfunctionJun 13, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2024, AN IVTM THERAPY (NORMOTHERMIA) WAS INITIATED FOR A STROKE PATIENT USING AN ICY CATHETER (LOT #189836). THE NEXT MORNING, ON (B)(6) 2024, THE HOSPITAL TEAM NOTED THAT THE 500 ML SALINE BAG EMPTIED MORE THAN USUAL. PER THE NURSE, THE TEAM ASSESSED ANY LEAKED SALINE AROUND THE THERMOGARD SYSTEM, ON THE PATIENT'S BED, OR LOOSE CONNECTIONS, BUT IT WAS UNCLEAR IF A GOOD ASSESSMENT WAS PERFORMED. SO, THE NURSE TROUBLESHOT THE CATHETER BY PERFORMING THE LEAK CHECK PER IFU. THE SALINE RETURNED AS EXPECTED, AND NO BLOOD WAS NOTED WHILE HOLDING THE VACUUM. THE TEAM REPLACED THE START-UP KIT (SUK) AND SALINE BAG TO CONTINUE THE THERAPY. THE FOLLOWING MORNING, ON (B)(6) 2024, THE TEAM NOTED THAT THE 500 ML SALINE BAG WAS EMPTYING AGAIN MORE THAN USUAL. THE TEAM DECIDED TO PUT THE THERMOGARD XP IVTM SYSTEM ON STANDBY MODE AND REMOVE THE CATHETER. THE CATHETER WAS REMOVED, AND THE TEAM PLACED AN ESOPHAGEAL COOLING PROBE TO CONTINUE THE THERAPY. THE CUSTOMER SUSPECTS AROUND 500 ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE CATHETER AT THE TIME OF THE ISSUE WAS APPROXIMATELY 18 HOURS, AND REMOVAL WAS APPROXIMATELY 34 HOURS. NO CONSEQUENCES OR IMPACTS ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534157 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON MAY 18 AT 00:10 AM, THE CUSTOMER PLACED A PATIENT INTO CONTROLLED HYPOTHERMIA VIA IVTM THERAPY USING AN ICY CATHETER (LOT #196563) INSERTED INTO THE LEFT FEMORAL VEIN. THE TARGET TEMPERATURE OF 35°C WAS ACHIEVED AT 06:00 AM. AT AROUND 10:00 PM ON THE SAME DAY, AN "AIR TRAP" ALARM OCCURRED, THE CONSOLE'S PUMP ROTOR STOPPED, AND THE THERMOGARD SYSTEM WENT INTO STANDBY MODE. THE 500-ML SALINE BAG WAS EMPTY. THE USER INSPECTED THE ENTIRE TUBING CONNECTION AND FOUND NO BLOOD TINGE. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK BUT DID NOT FIND THE CAUSE OF THE SALINE LEAKAGE. THEREFORE, THE CUSTOMER REMOVED THE CATHETER AND DISCONNECTED THE START-UP KIT SUK (LOT #196355) ALONG WITH THE SALINE BAG. A NEW ICY CATHETER (LOT #196563) WAS INSERTED INTO THE SAME ACCESS SITE (LEFT FEMORAL VEIN) AND A NEW SUK (LOT #196606) WAS PRIMED WITH A FRESH 500-ML SALINE BAG TO CONTINUE THE TREATMENT. ON MAY 20 AT AROUND 03:00, THE CUSTOMER CHECKED THE SECOND BAG AND NOTICED THAT THE SALINE LEVEL HAD DECREASED. NO "AIR TRAP" ALARM HAD BEEN GENERATED YET. THE CUSTOMER INSPECTED THE SUK AND THE ICY CATHETER, AND NO BLOOD TINGE WAS IN THE TUBING. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK PER IFU AND SUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515992 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON MAY 18 AT 00:10 AM, THE CUSTOMER PLACED A PATIENT INTO CONTROLLED HYPOTHERMIA VIA IVTM THERAPY USING AN ICY CATHETER (LOT #196563) INSERTED INTO THE LEFT FEMORAL VEIN. THE TARGET TEMPERATURE OF 35°C WAS ACHIEVED AT 06:00 AM. AT AROUND 10:00 PM ON THE SAME DAY, AN "AIR TRAP" ALARM OCCURRED, THE CONSOLE'S PUMP ROTOR STOPPED, AND THE THERMOGARD SYSTEM WENT INTO STANDBY MODE. THE 500-ML SALINE BAG WAS EMPTY. THE USER INSPECTED THE ENTIRE TUBING CONNECTION AND FOUND NO BLOOD TINGE. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK BUT DID NOT FIND THE CAUSE OF THE SALINE LEAKAGE. THEREFORE, THE CUSTOMER REMOVED THE CATHETER AND DISCONNECTED THE START-UP KIT SUK (LOT #196355) ALONG WITH THE SALINE BAG. A NEW ICY CATHETER (LOT #196563) WAS INSERTED INTO THE SAME ACCESS SITE (LEFT FEMORAL VEIN) AND A NEW SUK (LOT #196606) WAS PRIMED WITH A FRESH 500-ML SALINE BAG TO CONTINUE THE TREATMENT. ON MAY 20 AT AROUND 03:00, THE CUSTOMER CHECKED THE SECOND BAG AND NOTICED THAT THE SALINE LEVEL HAD DECREASED. NO "AIR TRAP" ALARM HAD BEEN GENERATED YET. THE CUSTOMER INSPECTED THE SUK AND THE ICY CATHETER, AND NO BLOOD TINGE WAS IN THE TUBING. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK PER IFU AND SUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515991 ↗
• MalfunctionJun 8, 2024Insufficient Cooling; Insufficient Cooling

  A PHYSICIAN INSERTED THE CATHETER (LOT# UNKNOWN) INTO THE PATIENT'S FEMORAL VEIN DURING THE IVTM THERAPY. PER THE REPORTER, THE PLACEMENT WAS DIFFICULT AS PROVIDERS STRUGGLED WITH PLACING THE LINE INITIALLY. THE CUSTOMER NOTICED THAT THE RED FLOW INDICATOR ON THE START-UP KIT (SUK) (LOT# UNKNOWN) WAS NOT ROTATING AND THE PATIENT WAS NOT COOLING TO THE TARGET TEMPERATURE. THE SUK WAS TESTED ON THE CLOSE LOOP AND THE RED FLOW INDICATOR WAS SPINNING, CONFIRMING A NORMAL FLOW. THE CUSTOMER WAS UNABLE TO FLUSH THE CATHETER OVER THE IN AND OUT LUERS WHEN USED WITH THE SYRINGE FILLED WITH SALINE. THE CUSTOMER WAS ADVISED TO REPLACE THE CATHETER AND UTILIZE THE BLANKET SURFACE SYSTEM TO REDUCE THE PATIENT'S TEMPERATURE FROM 37.6°C TO 37°C UNTIL A DECISION IS MADE REGARDING THE CATHETER REPLACEMENT. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 19494661 ↗
• MalfunctionMay 17, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT #196563) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO INITIATE AN IVTM THERAPY. FOUR HOURS LATER, THE COOLING TARGET TEMPERATURE OF 33 °C WAS ACHIEVED. AFTER ABOUT 16 HOURS INTO THE TREATMENT, DURING THE MAINTENANCE PHASE AFTER COOLING, THE NURSE OBSERVED A SIGNIFICANT DECREASE IN THE LEVEL OF SALINE SOLUTION IN THE 500-ML SALINE BAG. AROUND 100 MILLILITERS OF SALINE WERE LOST FROM THE BAG, SUSPECTED TO HAVE INFUSED INTO THE PATIENT'S BLOODSTREAM. THE PHYSICIAN DECIDED TO END THE TEMPERATURE MANAGEMENT TREATMENT PROCEDURE DUE TO THE PATIENT REGAINING CONSCIOUSNESS. BEFORE REMOVING THE CATHETER, A CATHETER LEAK CHECK WAS PERFORMED FOLLOWING ZOLL IFU INSTRUCTIONS. A RED/BLOOD TINGE IN THE TURNING WAS OBSERVED, INDICATING A LEAK FROM THE CATHETER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347101 ↗
• MalfunctionApr 25, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT #UNKNOWN) WAS USED IN AN IVTM THERAPY. AT SOME POINT DURING THE TREATMENT, THE NURSE NOTICED VOLUME DEPLETION ON THE SALINE BAG WITHOUT THE THERMOGARD SYSTEM GENERATING AN "AIR TRAP" ALARM. WHEN ZOLL TECH LINE CALLED THE CUSTOMER, THE NURSE REPORTED THAT THE CATHETER HAD BEEN REMOVED DUE TO A SUSPECTED LEAK. THE CUSTOMER DID NOT REPORT AT WHAT STAGE OF THERAPY THE ISSUE WAS NOTED; HOWEVER, THE PATIENT WAS WARMED BY THE TIME THE CATHETER WAS REMOVED, AND THE TREATMENT WAS COMPLETED. THE PATIENT NO LONGER NEEDED THE IVTM THERAPY. THERE WASN'T ANY BLOOD NOTICED IN THE TUBING PRIOR TO REMOVAL. THE REPORTING REGISTERED NURSE STATED THAT THE UNION OF THE CATHETER AND START-UP KIT (SUK) ORANGE LUERS APPEARED TO HAVE BEEN LOOSE. HOWEVER, THEY DID NOT OBSERVE ANY SALINE LEAKAGE FROM THE UNION OF THE CATHETER AND SUK ORANGE LUERS. NO ISSUE WAS REPORTED ON THE SUK. THE NURSE REPORTED NO SUSPECTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188229 ↗
• MalfunctionApr 11, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 188015) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO INITIATE AN IVTM THERAPY. DURING PREPARATION TO START THE TREATMENT, IT WAS NOTED THAT MEDICATION LEAKED FROM THE CATHETER'S MEDIAL LUMEN DUE TO A TEAR OUTSIDE THE LUMEN BODY. THE CUSTOMER FOUND THE TEAR IN THE MEDIAL LUMEN AND SUSPECTED THAT THE LUMEN'S PLASTIC CLAMP POSSIBLY HAD CAUSED IT. THE CATHETER WAS REMOVED, AND A NEW ICY CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. THE IVTM WAS THEN STARTED AND COMPLETED WITH THE SAME THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093809 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE ICY CATHETER (LOT# 195077) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH SOME RESISTANCE WHILE INSERTING THE CATHETER. THERE WAS NO OTHER CENTRAL LINE PLACED ON THE SAME VEIN DURING THE TREATMENT. AFTER THE CATHETER WAS SUCCESSFULLY PLACED, A RED TINGE IN THE TUBING (IN/OUT) WAS NOTED. THE ICY CATHETER LEAK CHECK WAS NOT PERFORMED. THE PHYSICIAN REPLACED ONLY THE ICY CATHETER TO INITIATE THE THERAPY. THE PHYSICIAN DID NOT NOTICE ANY ISSUE WITH THE GUIDEWIRE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882811 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 188020) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN FOR IVTM THERAPY. IN ADDITION, A RIGHT FEMORAL ARTERIAL LINE WAS PLACED TO MONITOR THE PATIENT'S BLOOD PRESSURE. DURING THE MAINTENANCE PHASE, THE SALINE BAG WAS NOTED AS EMPTY. THE NURSE REPORTING THE ISSUE WAS ADVISED TO CHECK THE FLUID IN THE AIRTRAP RACEWAY, UNDER THE CONSOLE, AND IN THE PATIENT BED; HOWEVER, NO EVIDENCE OF A LEAK WAS OBSERVED. PER THE REPORTER, THE SALINE BAG WAS NOT REPLACED. THE CATHETER LEAK WAS SUSPECTED AND THE CUSTOMER WAS ADVISED TO REPLACE THE LINE. THE PHYSICIAN WILL INSTALL A NEW LINE, ACCORDING TO THE NURSE. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 18638424 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE PHYSICIAN INSERTED AN ICY CATHETER (LOT #189629) INTO THE PATIENT'S LEFT FEMORAL VEIN TO INITIATE AN IVTM THERAPY. AFTER CATHETER INSERTION, AND UPON CHECKING THE CATHETER POSITION, THE PHYSICIAN NOTICED A RED TINGE IN THE IN AND OUT LUER TUBINGS. THE CATHETER WAS IMMEDIATELY REPLACED WITH ANOTHER ICY CATHETER TO INITIATE THE THERAPY. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544329 ↗
• MalfunctionJan 12, 2024Difficult to Advance; Difficult to Advance

  THE PHYSICIAN ATTEMPTED TO INSERT THE ICY CATHETER (LOT # 189629) ON THE RIGHT FEMORAL VEIN BUT OBSERVED AN EVIDENT RESISTANCE WITH THE GUIDEWIRE, AND THE CATHETER COULD NOT BE ADVANCED. A NEW ICY CATHETER AND THE GUIDEWIRE WERE PLACED SMOOTHLY ON THE SAME LOCATION TO CONTINUE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509198 ↗
• MalfunctionJan 12, 2024Insufficient Cooling; Insufficient Cooling

  DURING THE INITIATION PHASE OF THE IVTM THERAPY USING AN ICY CATHETER (LOT #188015), THE NURSE NOTICED THAT THE PATIENT WAS NOT REACHING THE TARGET TEMPERATURE AND THE START-UP KIT (SUK) PINWHEEL WAS NOT ROTATING. THE NURSE TESTED THE SUK IN A CLOSED LOOP, AND THE PINWHEEL ROTATED AS INTENDED. HOWEVER, WHEN THE SUK WAS RECONNECTED BACK TO THE CATHETER, THE PINWHEEL WOULD NOT ROTATE. THE ROLLER PUMP IN THE THERMOGARD XP IVTM SYSTEM WAS ROTATING, AND NO ALARMS WERE GENERATED. THE PATIENT'S TEMPERATURE WAS 37.4 DEGREES, WITH THE TARGET TEMPERATURE AT 34 DEGREES. THE CATHETER LEAK CHECK WAS PERFORMED, AND THERE WAS NO SIGN OF A LEAK. THERE WAS NO DECREASE IN SALINE VOLUME FROM THE SALINE BAG, AND IT WAS NEVER REPLACED. THE CATHETER DWELL TIME IS UNKNOWN. THE PATIENT'S HEIGHT IS 4FT AND 11 INCHES AND WEIGHS 74 KG. PER THE NURSE, THE CATHETER WILL BE REPLACED, AND NOT HUB ALL THE WAY IN CASE LENGTH IS AN ISSUE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509089 ↗
• MalfunctionDec 29, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT #192504) AND START-UP KIT (SUK) (LOT #192667) WERE USED IN INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY. THE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITHOUT DIFFICULTIES, AND NO NEARBY INVASIVE LINES WERE PLACED. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, AFTER RE-WARMING THE PATIENT, THE THERMOGARD SYSTEM DISPLAYED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. UPON INSPECTION, STAFF OBSERVED A LOW SALINE LEVEL IN THE 500-ML SALINE BAG, FROTHY SALINE SOLUTION, AND AIR BUBBLES IN THE TUBING. THERE WAS NO BLOOD TINGE IN THE TUBING. SINCE THE PATIENT WAS ALREADY RE-WARMED, THE THERAPY WAS ENDED. THE DWELL TIME OF THE CATHETER WAS ABOUT TWO DAYS (FROM (B)(6) THROUGH (B)(6)). NO CONSEQUENCES OR IMPACTS ON THE PATIENT. THE ICU MANAGER LATER OBSERVED THAT THE SUK WAS NOT SPIKED PROPERLY BUT WAS UNSURE WHETHER THE LEAK WAS FROM THE CATHETER OR THE SUK. THE STAFF HAD NOT SPECIFIED IF THERE WAS SALINE ON THE FLOOR OR IN THE PATIENT'S BED TO SIGNAL IMPROPER SPIKING OF THE SALINE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422193 ↗
• MalfunctionOct 21, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE IVTM THERAPY, THE ICY CATHETER (LOT# 181055) WAS PLACED IN THE RIGHT FEMORAL VEIN AFTER THE FIRST ATTEMPT. DURING THE COOLING PHASE, THE FOLLOWING MORNING, THE BLOOD WAS NOTED IN THE START-UP KIT (SUK) AIR TRAP AND THE SALINE BAG. THE CATHETER WAS NOT REPLACED AS THE PATIENT COULD MAINTAIN TEMPERATURE WITHIN GOAL. THE CUSTOMER SUSPECTED THE CATHETER LEAK AND THE INFUSION OF APPROXIMATELY 3/4 OF THE 500ML SALINE BAG AFTER THE CATHETER WAS REMOVED AND INSPECTED FOR TEAR. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981624 ↗
• MalfunctionOct 5, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT #189629) WAS SMOOTHLY INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INDUCE HYPOTHERMIA. DURING MAINTENANCE AFTER COOLING, 15 HOURS AFTER THE INITIATION OF THE TREATMENT, THE CUSTOMER OBSERVED THAT THE SALINE SOLUTION HAD TURNED TO A LIGHT PINK COLOR IN THE SALINE BAG. THE SYSTEM WAS INSPECTED, AND BLOOD TINGE WAS OBSERVED IN THE START-UP KIT (SUK) TUBING. THE CUSTOMER NOTICED THE ISSUE BEFORE THE THERMOGARD SYSTEM GENERATED AN AIR TRAP ALARM. THE PHYSICIAN SUSPECTED A CATHETER BALLOON RUPTURE/LEAK. THE SALINE BAG DID NOT DECREASE MUCH, AND THE CUSTOMER SUSPECTED LESS THAN 250 MILLILITERS OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE CATHETER AND SUK WERE REPLACED, AND THE TREATMENT WAS CONTINUED AND COMPLETED USING THE SAME THERMOGARD CONSOLE. THE REPORTED EVENT DID NOT IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882997 ↗
• MalfunctionJul 27, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER CALLED TO REPORT THE SALINE BAG EMPTIED ON THE PATIENT DURING THE REWARMING PHASE OF IVTM TREATMENT. NO BLOOD WAS NOTED IN THE TUBING. SALINE WAS NOTED IN THE BED AROUND THE PATIENT. THE COOLGARD 3000 IVTM SYSTEM DISPLAYED AN AIR TRAP ALARM THAT WAS CLEARED. THE EXACT LOCATION OF THE LEAK ON THE ICY CATHETER (LOT UNKNOWN) IS UNKNOWN. ABOUT 300 ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM IS SUSPECTED. THE CUSTOMER REPORTED HE DID NOT CHANGE THE SALINE BAG AND THERAPY WAS ENDED. THE PATIENT WAS NEAR NORMOTHERMIA AT THE TIME. THE CATHETER WAS PLACED IN THE LEFT FEMORAL REGION WITH NO OTHER LINES AT THAT SITE. THE DWELL TIME WAS BETWEEN 1-2 DAYS. NO DEVICE MALFUNCTION WAS REPORTED FOR THE START-UP KIT (SUK). NO HARM TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410341 ↗
• MalfunctionJul 27, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 188015) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN FOR IVTM THERAPY. DURING THE MAINTENANCE PHASE OF COOLING, THE THERMOGARD CONSOLE DISPLAYED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. THE NURSE OBSERVED BLOOD IN THE START-UP KIT (SUK) TUBING AND NOTICED THAT THE 500-ML SALINE BAG HAD EMPTIED. THE NURSE REPLACED THE SALINE BAG TO RESUME THE THERAPY. INITIALLY, IT WAS REPORTED THAT THE SECOND SALINE BAG RAN EMPTY AS WELL. HOWEVER, UPON FOLLOW-UP, THE CUSTOMER STATED THAT AFTER REPLACING THE FIRST SALINE BAG, THEY CONTACTED THE ZOLL IMMEDIATELY. THE ZOLL CLINICAL TEAM ADVISED THE CUSTOMER TO REMOVE THE CATHETER. THE DWELL TIME OF THE CATHETER WAS ABOUT TWO DAYS (LESS THAN 24 HOURS). THE CATHETER WAS REPLACED, AND THE TREATMENT CONTINUED AND WAS COMPLETED WITH THE SAME THERMOGARD CONSOLE. THE CUSTOMER SUSPECTED AN INFUSION OF 500 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE REPORTED INCIDENT DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409826 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE CUSTOMER OBSERVED LIGHT PINK COLOR IN THE SALINE BAG AND TRACES OF BLOOD TINGE IN THE SYRINGE. THE WHOLE CONNECTION WERE CHECKED FOR LEAK AND NO LEAK WAS OBSERVED. THE ICY CATHETER (LOT #184825), START-UP KIT (SUK) AND SALINE BAG WERE REPLACED AND CONTINUED WITH TREATMENT WITHOUT ANY ISSUE. PER REPORTER, AT THE FIRST TRY, THE CATHETER COULD NOT BE FULLY INSERTED, BUT THE SECOND TRY WAS A SMOOTH INSERTION INTO THE PATIENT LEFT FEMORAL VEIN. THE PHYSICIAN HAS CONDUCTED 4 TIMES IVTM HYPOTHERMIA PROCEDURE. THERE WAS NO ALARM FROM THE THERMOGARD CONSOLE DURING THE TREATMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17168522 ↗
• MalfunctionJun 6, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT DURING THE MAINTENANCE PHASE OF IVTM THERAPY, BLOOD-TINGED FLUID WAS SEEN IN THE SALINE BAG AND IN THE LINES CONNECTING TO THE THERMOGARD XP IVTM SYSTEM. THE PATIENT WAS AT THE TARGET TEMP OF 33C. THE CONSOLE DID NOT ALARM AND THE SALINE BAG WAS NOT DEPLETED. THERAPY WAS STOPPED AND THE PHYSICIAN WAS NOTIFIED. A LEAK ON THE QUATTRO CATHETER (LOT UNKNOWN) IS SUSPECTED. THE CATHETER WAS PLACED IN THE RIGHT FEMORAL VEIN. THE DWELL TIME WAS APPROXIMATELY 2 DAYS. IVTM WAS DISCONTINUED BECAUSE THE PATIENT WAS BEING RE-WARMED ALREADY. NO DEVICE MALFUNCTION WAS REPORTED FOR THE CONSOLE OR THE START-UP KIT (SUK) (LOT UNKNOWN). NO IMPACT OR CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072513 ↗
• MalfunctionMay 6, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  PER THE REPORTER, THE ICY CATHETER (LOT# UNKNOWN) WAS PLACED IN THE RIGHT FEMORAL VEIN FOR THE TREATMENT UTILIZING THE IVTM SYSTEM. THERE WERE NO DOCUMENTED ISSUES DURING THE CATHETER PLACEMENT AND NO OTHER LINES WERE PLACED IN THE SAME VEIN. TWO DAYS AFTER THE TREATMENT STARTED, AT THE END OF THE RE-WARMING PHASE, THE USER OBSERVED BLOOD IN START-UP KIT (SUK) TUBING AND A DECREASED LEVEL OF SALINE IN THE BAG, CONFIRMING THE CATHETER LEAK. THE CONSOLE WAS STOPPED BY THE NURSE, AND THE THERAPY WAS DISCONTINUED AS THE PATIENT WAS REWARMED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882825 ↗
• MalfunctionApr 24, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  TOWARD THE COMPLETION OF THE IVTM THERAPY, 43 HOURS AFTER THE THERAPY STARTED, THE NURSE NOTED AN EMPTY 500ML SALINE BAG AND THE AIR TRAP ALARM WENT OFF ON THE THERMOGARD CONSOLE. THE ICY CATHETER (LOT# UNKNOWN) WAS REMOVED AND THE CATHETER LEAK WAS OBSERVED BY THE CUSTOMER. NO CONSEQUENCES OR IMPACT TO THE PATIENT. CURRENT PATIENT STATUS: AWAKE, TRACKING FOLLOWING COMMANDS, AND MOVING ALL EXTREMITIES. THE CONSOLE WAS VERIFIED TO BE FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793349 ↗
• MalfunctionApr 24, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT UNDERWENT IVTM THERAPY FOR HYPOTHERMIA AT 13:50 ON MARCH 24TH. AT 16:00 ON THE SAME DAY, IT WAS NOTICED THAT THE START-UP KIT (SUK) (LOT# 180079) PINWHEEL WAS NOT SPINNING. THE PHYSICIAN ADJUSTED THE ICY CATHETER (LOT# 178513) BY PULLING IT OUT AROUND 4CM, AFTER WHICH THE PINWHEEL STARTED TO ROTATE. AT 05:30 ON MARCH 25TH, THE TUBING CONNECTION OF THE SUK AT THE CHECK VALVE BECAME DISCONNECTED. THE PHYSICIAN RECONNECTED IT, AND THE SYSTEM RESUMED NORMAL OPERATION. LATER, AT 18:50 ON MARCH 25TH, THE USER NOTICED A DECREASE IN SALINE, BUT THERE WERE NO SIGNS OF SALINE ON THE FLOOR OR BED. A NEW SUK WAS INSTALLED, BUT THE SALINE LEVELS CONTINUED TO DECREASE. FOLLOWING THE "LEAK INVESTIGATION INSTRUCTION," ALL CONNECTIONS WERE CHECKED, BUT NOTHING ABNORMAL WAS FOUND. THE CUSTOMER FOLLOWED THE IFU AND DID NOT REPLACE THE SALINE BAG PRIOR TO THE LEAK INVESTIGATION. THE ICY CATHETER WAS REPLACED AND THE TREATMENT CONTINUED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793337 ↗
• MalfunctionFeb 7, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AFTER 3 1/2 HOURS OF IVTM THERAPY, THE CONSOLE GENERATE THE AIR TRAP ALARM AND THE 500ML SALINE BAG HAD EMPTIED. THERE WERE NO TRACES OF SALINE ON THE BED OR THE FLOOR. THE ICY CATHETER (LOT # 170887) AND THE TUBING WERE CHECKED AS PER IFU, AND THE CATHETER LEAK WAS SUSPECTED. THE ICY CATHETER WAS REPLACED, AND THE THERAPY CONTINUED WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314910 ↗