ICY® Intravascular Heat Exchange Catheter Kit Applause Custom Luer IC-3893CORecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00849111075527), received between May 7, 2018 and Jan 27, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (27 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Fluid/Blood Leak; Material Integrity Problem

  BEFORE INSERTING THE ICY CATHETER (LOT # 197872), A BALLOON INTEGRITY TEST WAS CONDUCTED USING NORMAL SALINE FLUSHING. A LEAK WAS DETECTED IN THE CATHETER BALLOON, AND THE USE OF THE ICY CATHETER WAS IMMEDIATELY DISCONTINUED. A SECOND ICY CATHETER WAS THEN USED AND FUNCTIONED PROPERLY THROUGHOUT THE EVALUATION. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196419 ↗
• MalfunctionDec 27, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IN THE EMERGENCY DEPARTMENT, BEFORE PLACING THE ICY CATHETER (LOT# 197872), BALLOON LEAKAGE WAS IDENTIFIED DURING THE SALINE FLUSH TEST PERFORMED TO VERIFY BALLOON INTEGRITY WHEN THE CATHETER WAS CONNECTED TO THE CONSOLE. AS A RESULT, THE CATHETER WAS IMMEDIATELY REMOVED FROM USE. AN ALTERNATIVE TEMPERATURE MANAGEMENT THERAPY WAS UTILIZED TO CONTINUE THE PATIENT'S TREATMENT. NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901443 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  WHEN THE PHYSICIAN OPENED THE ICY CATHETER KIT (LOT # 191568) AND TESTED THE CATHETER PRIOR TO INSERTION FOR AN IVTM THERAY, A LEAK WAS DETECTED IN THE CATHETER'S BALLOON. A NEW CATHETER WAS USED TO START THE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692356 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE CUSTOMER NOTICED THAT THE SALINE WAS DECREASING IN THE 500 ML BAG. THE CUSTOMER CHECKED FOR LEAKS FROM THE START-UP KIT (SUK) BUT FOUND NO LEAKS, SO THE CUSTOMER SUSPECTED A DAMAGED ICY CATHETER (LOT# 184646). THE CUSTOMER PERFORMED THE LEAK CHECK PER IFU. THE CATHETER WAS REMOVED, AND THERAPY WAS CONTINUED WITH ARCTIC SUN. PER THE REPORTER, THE CATHETER WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068604 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT #184646) AND START-UP KIT (SUK) (LOT #185649) WERE UTILIZED TO PROVIDE IVTM THERAPY TO A POST-CARDIAC ARREST PATIENT. APPROXIMATELY 24 HOURS AFTER STARTING THE IVTM THERAPY, THE CUSTOMER NOTICED THAT THE SALINE SOLUTION IN THE BAG HAD TURNED YELLOW. THE CUSTOMER FELT THE VOLUME OF THE SALINE SOLUTION IN THE BAG APPEARED TO HAVE DECREASED TO 150 ML. NO "AIR TRAP" ALARM WAS REPORTED TO HAVE BEEN DISPLAYED BY THE THERMOGARD CONSOLE. THERE WERE NO REPORTS OF SALINE SOLUTION ON THE PATIENT'S BED, FLOOR, OR CONSOLE. UPON FOLLOW-UP, IT WAS CONFIRMED THAT THE SALINE BAG WAS PROPERLY SPIKED, AND THE CUSTOMER WAS AWARE THAT AROUND 200-250 ML OF SALINE SOLUTION HAD CIRCULATED IN THE TGXP CLOSED-LOOP SYSTEM. THERE WERE NO REPORTS OF POTENTIAL SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. DESPITE THE ABSENCE OF CONFIRMED SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM OR ANY CLEAR SIGNS OF A LEAK FROM THE SYSTEM, THE CUSTOMER WAS CONCERNED ABOUT A POTENTIAL CATHETER LEAK. THE CUSTOMER REPLACED BOTH THE ICY CATHETER AND THE SUK AND COMPLETED THE TREATMENT WITH THE SAME THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738095 ↗
• MalfunctionSep 1, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS INITIATED FOR A CPA PATIENT USING A ICY CATHETER (LOT 172325) ON 8/7/23. THE CUSTOMER FOUND THAT THERE WAS BLOOD IN THE CATHETER ON 8/8/23 AND REPLACED THE CATHETER WITH A NEW ONE TO CONTINUE THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674699 ↗
• MalfunctionAug 25, 2023Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem; Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023 AT 19:00, DURING PREPARATION FOR IVTM THERAPY, THEY COULD NOT USE ICY CATHETER #1 (LOT UNKNOWN) BECAUSE OF THE BALLOON DAMAGE. THE CUSTOMER REPLACED THE DAMAGED CATHETER WITH ANOTHER ICY CATHETER #2 (LOT UNKNOWN), BUT THE REPLACED CATHETER ALSO COULD NOT BE USED BECAUSE OF THE BALLOON DAMAGE. THE BALLOON DAMAGE WAS FOUND BEFORE INSERTION OF THE CATHETERS DURING THE LEAK CHECK OF THE CATHETERS. AFTER REPLACING WITH A NEW CATHETER AGAIN, THE CUSTOMER COULD BEGIN THE IVTM THERAPY WITH NO FURTHER ISSUES. THERAPY ENDED ON (B)(6) 2023 WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2023-00722 FOR THE ICY CATHETER #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628173 ↗
• MalfunctionAug 25, 2023Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem; Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023 AT 19:00, DURING PREPARATION FOR IVTM THERAPY, THEY COULD NOT USE ICY CATHETER #1 (LOT 184646) BECAUSE OF THE BALLOON DAMAGE. THE DAMAGE RESULTED IN CATHETER LEAKAGE. THE CUSTOMER REPLACED THE DAMAGED CATHETER WITH ANOTHER ICY CATHETER #2 (LOT 184646), BUT THE REPLACED CATHETER ALSO COULD NOT BE USED BECAUSE OF THE BALLOON DAMAGE. THE BALLOON DAMAGE WAS FOUND BEFORE INSERTION OF THE CATHETERS DURING THE LEAK CHECK OF THE CATHETERS. AFTER REPLACING WITH A NEW CATHETER AGAIN, THE CUSTOMER COULD BEGIN THE IVTM THERAPY WITH NO FURTHER ISSUES. THERAPY ENDED ON (B)(6) 2023 WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627312 ↗
• MalfunctionAug 15, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  TWO HOURS AFTER INITIATING AN IVTM THERAPY USING THE ICY CATHETER (LOT #184646), THE CUSTOMER REPORTED OBSERVING BLOOD IN THE START-UP KIT (SUK) TUBING. THE CUSTOMER NOTICED THIS BEFORE THE THERMOGARD SYSTEM GENERATED ANY "AIR TRAP" ALARM, AND THERE WAS NO REPORT OF A DECREASE IN THE SALINE BAG VOLUME. THE CUSTOMER PAUSED THE THERMOGARD CONSOLE, REMOVED THE CATHETER, AND NOTICED BLOOD IN THE CATHETER AS WELL. THE CUSTOMER SUSPECTED A CATHETER LEAK AND REPLACED THE CATHETER. THE CUSTOMER ALSO DECIDED TO REPLACE THE SUK DUE TO THE PRESENCE OF BLOOD IN THE TUBING. IT IS UNKNOWN HOW MUCH SALINE MIGHT HAVE INFUSED INTO THE PATIENT'S BLOODSTREAM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549926 ↗
• MalfunctionFeb 17, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2023 AT 12:50 PM, A CARDIOPULMONARY ARREST (CPA) PATIENT (81 YEARS OLD FEMALE) WITH A TEMPERATURE OF 28.7°C WAS BROUGHT TO THE HOSPITAL. THE IVTM THERAPY USING AN ICY CATHETER (LOT # 181290) BEGAN AT 1:37 PM. ON (B)(6) 2023, AT 0:15 AM, DURING THE WARMING PHASE OF THE TREATMENT, AN AIR TRAP ALARM WENT OFF AND THE DEVICE WAS PAUSED. THE CUSTOMER DISCOVERED THAT THE SALINE BAG WAS NEARLY EMPTY (ABOUT 200ML OF SALINE HAD BEEN INFUSED) AND THERE WAS A BACKFLOW OF BLOOD IN THE START-UP KIT (SUK) (LOT # 182403), CONFIRMING THE CATHETER LEAK. THE CUSTOMER DECIDED TO REMOVE THE CATHETER, HOWEVER, THE REASON FOR NOT CONTINUING THE IVTM THERAPY WAS NOT PROVIDED. AT 1:13 PM, THE CUSTOMER CONFIRMED THE PATIENT'S DEATH. AT THE TIME OF DEATH, THE PATIENT HAD A FEVER OF MORE THAN 39°C. THE REQUEST FOR ADDITIONAL INFORMATION RECEIVED LIMITED RESPONSE. THE RELATIONSHIP BETWEEN THE CATHETER LEAK AND DEATH IS UNKNOWN. THE CONSOLE WAS VERIFIED TO BE FUNCTIONAL.

  Patient problems: Cardiac Arrest

  MAUDE report 16397988 ↗
• MalfunctionJan 17, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 178944) WAS SMOOTHLY INSERTED INTO THE FEMORAL VEIN OF A POST-CARDIAC ARREST PATIENT FOR IVTM THERAPY. DURING THE COOLING PHASE OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. THE CUSTOMER OBSERVED A BACKFLOW OF BLOOD INTO THE START-UP KIT (SUK) TUBING. THE CUSTOMER SUSPECTED A CATHETER BALLOON LEAK AND AN UNKNOWN AMOUNT OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE CUSTOMER REMOVED THE CATHETER AND ENDED THE TEMPERATURE MANAGEMENT TREATMENT. THERE WAS NO MALFUNCTION WITH THE THERMOGARD CONSOLE. NO OTHER DEVICE WAS USED TO CONTINUE THE TREATMENT AS THE PHYSICIAN DETERMINED THAT THE PATIENT DID NOT NEED TEMPERATURE MANAGEMENT THERAPY ANYMORE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16189900 ↗
• MalfunctionJan 9, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2022, IVTM THERAPY (REWARMING) USING THE ICY CATHETER (LOT #178944) FOR A HYPOTHERMIC PATIENT BEGAN. ON (B)(6) IN THE MORNING, A NURSE CALLED THE CLINICAL ENGINEER SAYING THAT THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN "AIR TRAP" ERROR MESSAGE AND THE SALINE IN THE SALINE BAG WAS DECREASING. REWARMING WAS COMPLETE BUT CATHETER WAS NOT REMOVED RIGHT AWAY BECAUSE IT WAS CONTINUED TO BE USED AS A CVC. THE DWELL TIME WAS APPROXIMATELY 48 HOURS. THE EXACT LOCATION OF THE LEAK IS UNKNOWN. NO DEVICE MALFUNCTION WAS REPORTED FOR THE CONSOLE OR THE START-UP KIT (SUK). THE CONSOLE IS BACK IN SERVICE. ON (B)(6), THE CATHETER WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121797 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2022, IVTM THERAPY BEGAN. ON (B)(6) 2022, THE SALINE BAG WAS OBSERVED TO BE ALMOST EMPTY AND THE SALINE SOLUTION IN THE AIR TRAP WAS ALSO DECREASED. AFTER CHECKING THAT NO SALINE WAS LEAKING FROM AROUND THE CONSOLE, THE CUSTOMER DETERMINED THAT THE ICY CATHETER (LOT #173639) WAS THE CAUSE OF THE SALINE LEAK AND REPLACED THE CATHETER. THE START-UP KIT (SUK) (LOT # 171714) WAS REPLACED JUST IN CASE. NO DEVICE MALFUNCTION WAS REPORTED FOR THE SUK. AFTER REPLACING THE ICY CATHETER AND SUK, IVTM THERAPY CONTINUED WITH THE SAME CONSOLE WITHOUT ANY PROBLEMS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252215 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE 3RD DAY OF IVTM THERAPY ON A RESUSCITATED PATIENT, CUSTOMER OBSERVED THAT THE PATIENT HAD HIGH D-DIMER LEVELS BUT DID NOT FIND LOWER LIMB DEEP VEIN THROMBOSIS (DVT). THE ICY CATHETER (LOT #UNKNOWN) WAS REMOVED AND WHEN PRESSURE WAS APPLIED TO THE INSERTION SITE TO STOP THE BLEEDING, THE CUSTOMER OBSERVED THAT THE PATIENT'S BREATHING AND PULSE WERE ABNORMAL. THE PATIENT'S LUNGS WERE CHECKED, AND EMBOLISM WAS FOUND IN BOTH MAIN BRONCHI OF THE LUNGS. AFTER CONSULTING WITH THE CARDIOLOGY DEPARTMENT, THE CUSTOMER DECIDED NOT PERFORM THROMBOLYSIS AND CONTINUE TO MONITOR THE PATIENT. BLOOD CLOTS WERE OBSERVED WHEN THE ICY CATHETER WAS REMOVED. NO ISSUES WITH THE CATHETER OR SUK. AS OF (B)(6) 2022, THE PATIENT'S HEALTH HAVE IMPROVED AND THE BLOOD CLOTS ARE GONE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: 3010617000-2022-01266 FOR THE START-UP KIT (LOT #UNKNOWN).

  Patient problems: Pulmonary Embolism

  MAUDE report 15127083 ↗
• MalfunctionJun 27, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2022, THE ICY CATHETER (LOT #173639) WAS PLACED IN THE PATIENT WHO WAS RESUSCITATED FROM CARDIAC ARREST. IVTM THERAPY WAS STARTED AND APPROXIMATELY AN HOUR AND A HALF LATER, THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN AIR TRAP ALARM AND THE CONSOLE WENT INTO STANDBY MODE. THE SALINE BAG WAS OBSERVED TO BE EMPTY. THE CUSTOMER OBSERVED SOME DISCOLORATION IN THE TUBING OF THE START-UP KIT (SUK) THAT WAS THOUGHT TO BE BACKFLOW OF BLOOD. THERE WAS NO EVIDENCE OF LEAKAGE AROUND THE CONSOLE, AND THE CUSTOMER DETERMINED THAT IT WAS A LEAK FROM THE BALLOON OF THE ICY CATHETER. THE CUSTOMER TRIED TO CHECK THE INSTRUCTIONS FOR CHECKING LEAKS, AND A FOREIGN METAL OBJECT BELIEVED TO BE A RAZOR FELL OUT OF THE OUTER BOX (THE BOX CONTAINING THE KIT). THE CUSTOMER REMOVED THE ICY CATHETER FROM THE PATIENT AND DISCONTINUED IVTM THERAPY. THE DWELL TIME WAS APPROXIMATELY 5 HOURS. THE CONSOLE HAS NO ISSUES AND IS READY FOR USE. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838038 ↗
• MalfunctionMay 25, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AT NOON ON (B)(6),2022 IVTM THERAPY WAS STARTED WITH THE TARGET TEMPERATURE SET AT 36 DEGREES. THE PATIENT HAD BODY TEMPERATURE OF 38 DEGREES. THE ICY CATHETER (LOT #162644) WAS SMOOTHLY INSERTED IN THE RIGHT FEMORAL VEIN ON THE FIRST ATTEMPT. AT 18:00, NO DECREASE IN SALINE IN THE SALINE BAG WAS OBSERVED. AT AROUND 20:00, THE SALINE IN THE SALINE BAG HAD DECREASED BY ABOUT 10 ML, BUT THE CUSTOMER THOUGHT IT WAS DUE TO THE EXPANSION OF THE AIR IN THE SALINE BAG AND IVTM THERAPY WAS CONTINUED. AT MIDNIGHT ON (B)(6) 2022, DURING THE MAINTENANCE PHASE, THE CUSTOMER OBSERVED THAT THERE WAS ONLY 50ML OF SALINE LEFT IN THE SALINE BAG AND BACKFLOW OF BLOOD IN THE START-UP KIT (SUK) WAS OBSERVED. THE THERMOGARD XP IVTM SYSTEM DID NOT GENERATE AN AIR TRAP WARNING ALARM. THE CUSTOMER JUDGED THE ISSUE WAS DUE TO A BALLOON LEAK. ABOUT 200ML OF SALINE INFUSION WAS SUSPECTED AND IVTM THERAPY WAS DISCONTINUED BECAUSE THE TEMPERATURE WAS MAINTAINED. THE SUK WAS CHECKED FOR LEAKS BUT NONE WERE FOUND. THE DWELL TIME WAS APPROXIMATELY 36 HOURS. ON THE MORNING OF (B)(6) 2022, THE CATHETER WAS REMOVED. IT WAS NOT REMOVED AT MIDNIGHT BECAUSE DOCTOR WAS NOT THERE. NO DEVICE MALFUNCTION WAS REPORTED FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501670 ↗
• MalfunctionMay 17, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE THERMOGARD IVTM SYSTEM (B)(4) GENERATED AN ALARM AND IT DISPLAYED MID:01 POST WATCHDOG ERROR MESSAGE. THE CUSTOMER NOTED A NEARLY EMPTY 1000 ML SALINE BAG, BLOOD-TINGED IN START-UP KIT (SUK) TUBING, AND NO LEAKED SALINE NOTED AROUND THE PATIENT OR ON THE FLOOR AROUND THE THERMOGARD SYSTEM. AN ICY CATHETER LOT #UNKNOWN BALLOON LEAK WAS SUSPECTED. IT IS UNKNOWN HOW MUCH SALINE INFUSED INTO THE PATIENT'S BODY. PER THE REPORTER, IVTM THERAPY CONTINUED WITHOUT REPLACING THE SALINE BAG AND CATHETER BECAUSE THE PATIENT HAS COMPLETED THE COOLING PHASE AND IS NOW IN THE MAINTENANCE PHASE. ALSO, THE INTENSIVIST DID NOT WANT TO REMOVE THE CATHETER DUE TO THE PATIENT IS FULLY ANTICOAGULATED AND MAYBE AT RISK OF BLEEDING. NO OTHER LINES PRESENT AT THE INSERTION SITE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00499 FOR THE THERMOGARD CONSOLE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14418149 ↗
• MalfunctionMay 2, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE IVTM THERAPY WAS INITIATED FOR A POST-CARDIAC ARREST PATIENT USING AN ICY CATHETER (LOT #UNKNOWN). THE CATHETER WAS PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN, AND THE INSERTION WAS SMOOTH. WITHIN TWO DAYS OF THE INITIATION OF IVTM THERAPY, THE CUSTOMER NOTICED THAT THE SALINE BAG (500ML) HAD GRADUALLY DECREASED, ALMOST EMPTY. THE THERMOGARD SYSTEM WAS PUT IN STANDBY MODE. FOLLOWING THIS, THE CUSTOMER OBSERVED BLOOD BACKED UP INTO SUK TUBING. THE CUSTOMER SAW DECREASING SALINE VOLUME BEFORE THE THERMOGARD XP IVTM SYSTEM GENERATE AN "AIR TRAP WARNING" ALARM. THE CUSTOMER SUSPECTED A SALINE LEAK FROM THE ICY CATHETER BALLOON AND 200 TO 250 ML OF SALINE INFUSION INTO THE PATIENT. THE CATHETER WAS REMOVED, AND THE TREATMENT WAS CONTINUED WITH AN ALTERNATE TEMPERATURE MANAGEMENT DEVICE. THERE WAS NO MALFUNCTION REPORTED FOR THE CONSOLE AND THE DEVICE WAS PLACED BACK FOR CLINICAL USE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14258310 ↗
• MalfunctionApr 24, 2022Difficult to Advance; Difficult to Advance

  DURING THE ICY CATHETER (LOT # 172325) PLACEMENT FOR IVTM THERAPY, THE CUSTOMER EXPERIENCED DIFFICULTY WHILE ADVANCING THE CATHETER OVER THE GUIDEWIRE. THE USER USED A NEW GUIDEWIRE AND THE SECOND CATHETER WAS PLACED SUCCESSFULLY TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191176 ↗
• MalfunctionMar 14, 2022Use of Device Problem; Use of Device Problem

  AFTER 40 HOURS OF IVTM THERAPY FOR A PATIENT WITH CARDIOPULMONARY ARREST, THE THERAPY WAS PAUSED AND THE START-UP KIT (SUK) (LOT # 158572) WAS DISCONNECTED FROM THE QUATTRO CATHETER (LOT # 155959) FOR THE PATIENT EXAMINATION AND CONNECTED BACK 30 MINUTES LATER TO CONTINUE THE THERAPY. PER THE REPORTER, THE PINWHEEL WAS SPINNING AFTER THE CATHETER WAS RECONNECTED TO THE SUK AND NO KINKS OR OBSTRUCTIONS TO THE SUK TUBING WERE NOTED. THE CUSTOMER OBSERVED BLEEDING FROM THE CATHETER INSERTION SITE. THE PRESSURE WAS APPLIED TO MITIGATE THE BLEEDING. TWENTY MINUTES AFTER THE THERAPY RESTARTED THE USER HEARD A BURSTING NOISE AND THE LFL TUBE PORTION OF THE SUK JUST AFTER THE ROTOR PUMP WAS OBSERVED SWOLLEN AND TORN WITH SALINE LEAKING EXTERNALLY. THE THERMOGARD CONSOLE GENERATED THE AIR TRAP ALARM AND THE THERAPY WAS STOPPED. THE CUSTOMER VERIFIED THAT THE CATHETER WAS SECURE AND IN THE CORRECT DEPTH POSITION. THE CUSTOMER SUSPECTED THE CATHETER LEAK. THE CATHETER WAS REMOVED FROM THE PATIENT, HOWEVER, AFTER PERFORMING A BALLOON LEAK TEST ON THE CATHETER, THE SALINE LEAK WAS NOT CONFIRMED. THE TREATMENT WAS CONTINUED USING THE ALTERNATIVE TEMPERATURE MANAGEMENT DEVICE (BLANKET ROLL). THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13764708 ↗
• MalfunctionNov 22, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT UNDERWENT IVTM THERAPY AFTER CARDIAC ARREST. THE ICY CATHETER (LOT # 150201) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. THE CUSTOMER DID NOT PROVIDE THE PATIENT'S BODY TEMPERATURE AT THE START OF THE IVTM THERAPY. DURING THE MAINTENANCE PHASE OF THE TREATMENT, THE THERMOGARD SYSTEM DISPLAYED AN "AIR TRAP" ALARM. IT WAS NOTED THAT THE 500-ML SALINE BAG WAS EMPTY. THE DWELL TIME OF THE CATHETER WAS 90 HOURS WHEN THE ISSUE HAPPENED. NO TRACES OF SALINE WERE OBSERVED ON THE FLOOR, PATIENT'S BED, OR ON THE CONSOLE, RULING OUT THE POSSIBILITY OF EXTERNAL LEAKAGE FROM THE START-UP KIT (SUK). THE CUSTOMER DID NOT REPORT IF THERE WAS ANY BLOOD TINGE IN THE TUBING. SINCE THE THERAPY WAS ALMOST COMPLETED, THE CATHETER WAS REMOVED. THE CUSTOMER FLUSHED THE CATHETER BALLOONS WITH SALINE AND OBSERVED A LEAK FROM ONE OF THE BALLOONS. INFUSION OF ABOUT 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE CUSTOMER DID NOT REPORT ANY DEVICE MALFUNCTION ON THE THERMOGARD CONSOLE, AND THE CONSOLE WAS PLACED BACK ON THE FLOOR FOR FURTHER CLINICAL USE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858664 ↗
• MalfunctionFeb 19, 2021Crack; Material Integrity Problem; Crack; Material Integrity Problem

  APPROXIMATELY 9 HOURS AFTER THE INITIATION OF THE IVTM THERAPY, THE NURSE OBSERVED THAT THE SALINE BAG DECREASED AND BED SHEET WAS WET. FOLLOWING THIS, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) AND START-UP KIT WAS REPLACED. AFTER 5 HOURS AND 32 MINUTES, AGAIN SALINE LEAK WAS OBSERVED. THE USER REPLACED THE ICY CATHETER AND SUK. IT WAS OBSERVED THAT THERE WAS A CRACK ON THE INFLOW LEUR OF THE ICY CATHETER (LOT# 150505) . NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REOPRT: MFR # 3010617000-2021-00198 FOR THE THERMOGARD XP IVTM SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355218 ↗
• MalfunctionOct 23, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, A HOSPITAL PHYSICIAN NOTICED BLOOD IN THE FLOW INDICATOR ON THE START-UP KIT (SUK) AND SUSPECTED A ICY CATHETER (LOT #148834) LEAK. THE PHYSICIAN REMOVED THE CATHETER AND INSERTED A NEW CATHETER TO CONTINUE WITH IVTM TREATMENT. ISSUE WAS NOTICED AROUND HALF AN HOUR DURING TREATMENT. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 10731532 ↗
• MalfunctionSep 10, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON THE THIRD DAY OF IVTM THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM AND THE USER NOTICED THAT THE SALINE BAG WAS EMPTY. IT WAS SUSPECTED THAT THE ICY CATHETER (LOT #142550) WAS LEAKING. SINCE THE REWARMING PHASE OF THE THERAPY HAD BEEN COMPLETED, THE CATHETER WAS REMOVED. AFTER REMOVING THE CATHETER, THE USER FLUSHED THE CATHETER BALLOONS WITH SALINE AND NOTICED A PINHOLE LEAK FROM ONE OF THE BALLOONS. IT WAS SUSPECTED THAT THE REMAINING OF THE 500-ML SALINE BAG, AFTER THE SYSTEM SET-UP, HAD INFUSED INTO THE PATIENT'S BODY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518156 ↗
• MalfunctionJul 24, 2020Material Integrity Problem; Material Integrity Problem

  TO INITIATE THE PATIENT IVTM THERAPY, THE USER APPLIED ISODINE SOLUTION TO DISINFECT AND PREP THE PATIENT'S SKIN FOR CATHETER INSERTION. THE ICY CATHETER (LOT # 95028) INSERTION WAS PROCEEDING SMOOTHLY WITH NO UNUSUAL RESISTANCE INTO THE PATIENT'S FEMORAL VEIN; HOWEVER, WHEN THE CATHETER WAS HALF-WAY INSERTED, THE USER NOTED BLOOD AND SALINE DIFFUSED INTO THE LUMEN OF THE CATHETER. IT WAS SUSPECTED THAT ONE OF THE CATHETER BALLOONS WAS DAMAGED. SUBSEQUENTLY, THE ICY CATHETER WAS REPLACED, AND THE PATIENT IVTM TREATMENT WAS COMPLETED SUCCESSFULLY WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324178 ↗