ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin) IC-3893AERecalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 00849111075251), received between Jan 27, 2017 and Sep 23, 2026 — classified as 5 deaths, 13 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (153 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 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fluid/Blood Leak; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876278 ↗
• MalfunctionAug 27, 2026Insufficient Cooling

  Patient problems: Insufficient Information

  MAUDE report 50465570 ↗
• InjuryApr 11, 2026Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 216479) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN, AND HYPOTHERMIA TREATMENT STARTED AROUND 2 PM. ABOUT AN HOUR LATER, THE IVTM SYSTEM TRIGGERED AN "AIR TRAP" ALARM. UPON INSPECTION, THE DOCTOR FOUND THAT THE SALINE LEVEL HAD DECREASED BY ABOUT 200 ML. A CATHETER BALLOON LEAK CHECK WAS PERFORMED, AND THE LEAK WAS CONFIRMED. BECAUSE THE PATIENT HAD POOR BLOOD COAGULATION AND BLEEDING AT THE INSERTION SITE, THE CATHETER WAS NOT IMMEDIATELY REMOVED. A NEW ICY CATHETER WAS THEN PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN (OPPOSITE SIDE) TO CONTINUE TREATMENT USING THE SAME CONSOLE AND START-UP KIT (SUK). NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24845943 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT 218568) WAS PLACED VIA RIGHT FEMORAL AND THE IVTM THERAPY STARTED AT AROUND 10AM ON (B)(6) 2026. AT AROUND 8PM ON THE SAME DAY, THERE WAS AN AIR TRAP ALARM DISPLAYED ON THE THERMOGARD XP IVTM SYSTEM. THE DOCTOR CHECKED IT AND FOUND BLOOD IN THE SALINE IN THE CATHETER AND START-UP KIT (SUK) TUBING. THE BALLOON LEAK CHECK WAS CONDUCTED AND THE BALLOON RUPTURE WAS CONFIRMED. A NEW ICY CATHETER AND A NEW SUK WERE REPLACED TO CONTINUE THE TREATMENT WITH THE SAME CONSOLE. NO DEVICE MALFUNCTION IS REPORTED FOR THE SUK. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677095 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT UNDERWENT TARGETED TEMPERATURE MANAGEMENT (TTM) FOLLOWING CARDIOPULMONARY RESUSCITATION (CPR). THE ICY CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S FEMORAL VEIN ON THE FIRST ATTEMPT. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO THE IVTM THERAPY. THE PATIENT'S INITIAL TEMPERATURE WAS NOT REPORTED. THE TARGET TEMPERATURE WAS SET TO 34°C WITH THE RATE SET TO MAXIMUM. AFTER 70 HOURS OF THERAPY, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE ENTERED STANDBY MODE. THE 500 ML SALINE BAG WAS FOUND EMPTY, AND THE PATIENT'S TEMPERATURE AT THE TIME THE ISSUE OCCURRED WAS 36.5°C. NO FLUID WAS DETECTED ON THE THERMOGARD CONSOLE, THE PATIENT'S BED, OR THE FLOOR. IT WAS SUSPECTED THAT 200 ML OF SALINE SOLUTION MAY HAVE INFUSED INTO THE PATIENT'S BLOODSTREAM. NO MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE USED DURING THE EVENT. THE CATHETER WAS SUBSEQUENTLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136438 ↗
• MalfunctionDec 26, 2025Difficult to Insert; Difficult to Insert

  DURING THE INSERTION OF THE ICY CATHETER (LOT #UNKNOWN) FOR IVTM THERAPY INTO THE PATIENT'S LEFT FEMORAL VEIN, THE CUSTOMER WAS UNABLE TO ADVANCE THE CATHETER OVER THE GUIDEWIRE BECAUSE THE GUIDEWIRE WAS KINKED. THE CUSTOMER DISPOSED OF THE CATHETER. ANOTHER ICY CATHETER WAS SUCCESSFULLY INSERTED INTO THE RIGHT FEMORAL VEIN WITHOUT ANY ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898456 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT RECEIVED IVTM TO INDUCE HYPOTHERMIA. THE ICY CATHETER (LOT #211380) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN ON THE FIRST ATTEMPT. TWENTY-FOUR HOURS LATER, DURING THE MAINTENANCE AFTER COOLING, THE THERMOGARD SYSTEM TRIGGERED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. THE 500-ML SALINE BAG WAS FOUND EMPTY. NO FLUID WAS DETECTED ON THE THERMOGARD CONSOLE, THE PATIENT'S BED, OR THE FLOOR. THERE WAS NO BLOOD TINGE IN THE TUBING. AFTERWARDS, THE CATHETER WAS REMOVED AND REPLACED. THE TREATMENT CONTINUED AND WAS COMPLETED USING THE SAME THERMOGARD CONSOLE. THE CUSTOMER SUSPECTED THAT 250 MILLILITERS OF SALINE HAD BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560666 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT#: 212648) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INITIATE INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY TO INDUCE THERAPEUTIC HYPOTHERMIA. AROUND 5 MINUTES AFTER THE IVTM SYSTEM STARTED RUNNING, AN "AIR TRAP" ALARM WAS TRIGGERED. UPON INSPECTION, THE NURSE FOUND THAT THE SALINE LEVEL IN THE SALINE BAG HAD DECREASED TO AROUND 100 MILLILITERS. ADDITIONALLY, IT WAS OBSERVED THAT THE SALINE SOLUTION HAD TURNED LIGHT PINK IN BOTH THE BAG AND THE AIR TRAP CHAMBER. THE PHYSICIAN PERFORMED THE BALLOON LEAK CHECK ACCORDING TO THE ZOLL INSTRUCTIONS FOR USE (IFU) AND CONCLUDED THAT THERE SHOULD BE BALLOON RUPTURE/LEAKAGE. A NEW ICY CATHETER AND A NEW SUK WERE REPLACED TO CONTINUE THE HYPOTHERMIA. NO MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515421 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # 211380) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE ATTEMPT TO INITIATE HYPOTHERMIA AFTER CARDIAC ARREST. NO OTHER TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR ADJUNCT OR PRIOR TO THE IVTM THERAPY. AFTER 15 HOURS, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM. UPON INSPECTION, IT WAS NOTICED THAT BLOOD WAS RETURNING TO THE TUBING. THE CATHETER BALLOON WAS DEFECTIVE AND LEAKING. THE TREATMENT WAS FINISHED, AND THEREFORE, THE CATHETER WAS NOT REPLACED. THERE IS NO DEVICE MALFUNCTION ON THE THERMOGARD CONSOLE; IT IS FUNCTIONAL, AND IT HAS BEEN PLACED BACK ON THE FLOOR FOR FUTURE CLINICAL USE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT IS VENTILATED AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418418 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THE SALINE FLUID LEVEL WAS DEPLETED SUDDENLY DURING USE OF THE THERMOGARD XP IVTM SYSTEM. THE ICY CATHETER (LOT 202606) WAS CHECKED, AND NO LEAK WAS NOTED EXTERNALLY. THE CATHETER WAS SMOOTHLY INSERTED ON THE FIRST ATTEMPT ON (B)(6) 2025 AND THE LEAK WAS NOTICED ON (B)(6) 2025 AT 0030. TREATMENT WAS DISCONTINUED AND THE CATHETER WAS REMOVED ON THE SAME DAY. THE DWELL TIME WAS APPROXIMATELY 5 DAYS. APPROXIMATELY 500 ML OF SALINE INFUSION IS SUSPECTED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418385 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS INITIATED USING AN ICY CATHETER (LOT # 195238). DURING TREATMENT, THE THERMOGARD CONSOLE WAS REPORTED TO BE NOISY. AT AN UNSPECIFIED TIME, THE SALINE BAG WAS FOUND TO BE EMPTY. THE BAG WAS REPLACED, AND DURING ONE HOUR, A DROP IN THE SALINE LEVEL WAS OBSERVED. THE PATIENT RECEIVED APPROXIMATELY 250 ML OF SALINE INFUSION FROM THE FIRST BAG AND AN ADDITIONAL 50-100 ML FROM THE SECOND BAG. THE CUSTOMER SUSPECTED SALINE LEAKAGE FROM THE ICY CATHETER. ACCORDING TO THE REPORTER, THE CATHETER LEAK CHECK, AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU), WAS NOT PERFORMED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035569 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT THE ICY CATHETER (LOT # 201202) LEAKED AFTER INSERTION. PER THE CUSTOMER'S CLINICAL TECHNICIAN, THE TROUBLESHOOTING STEPS IN ZOLL'S INSTRUCTIONS FOR USE (IFU) FOR A CATHETER LEAK CHECK WERE PERFORMED ON THE BENCH AND INDICATED A LEAK. NO FURTHER INFORMATION WAS RECEIVED FROM THE CLINICAL TEAM. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 23034201 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT RECEIVED IVTM THERAPY FOR HYPOTHERMIA AFTER CARDIAC ARREST. THE ICY CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN ON A SINGLE ATTEMPT. NO ADDITIONAL TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED. THE PATIENT'S BODY TEMPERATURE AT THE START OF TREATMENT WAS 36.2°C, AND THE TARGET TEMPERATURE WAS SET TO 33.1°C WITH THE MAXIMUM COOLING RATE. ABOUT 48 HOURS AFTER STARTING THE TREATMENT, THE THERMOGARD SYSTEM TRIGGERED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE ENTERED STANDBY MODE. THE CUSTOMER NOTICED THE SALINE BAG WAS EMPTY. THERE WAS NO SALINE SOLUTION ON THE FLOOR, THE PATIENT'S BED, OR THE CONSOLE. THE CUSTOMER REPORTED THAT THE ISSUE HAPPENED DURING THE COOLING AND REWARMING PHASES, AND 500-ML SALINE BAGS RAN EMPTY FOUR TIMES. THE CUSTOMER ENDED THE TREATMENT WITHOUT REPLACING THE CATHETER. IT IS SUSPECTED THAT APPROXIMATELY 2000 ML OF SALINE MAY HAVE BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844219 ↗
• InjuryAug 15, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, APPROXIMATELY 50 HOURS INTO HYPOTHERMIA MANAGEMENT, A SALINE LEAK WAS OBSERVED AT THE VASCULAR ACCESS (PUNCTURE) SITE OF THE ICY CATHETER (LOT # 210055). UPON EVALUATION, THE ATTENDING PHYSICIAN IDENTIFIED THAT THE CATHETER HAD BECOME DISLODGED, HAVING MIGRATED OUTWARD FROM ITS ORIGINAL PLACEMENT. ACCORDING TO THE REPORTER, THE PATIENT WAS NOT MOVED OR TRANSPORTED BEFORE THE REPORTED ISSUE, AND THE CATHETER WAS SUTURED AND SECURED WITH CATHETER WINGS. THE SALINE LEAK, ESTIMATED TO BE AT A RATE OF APPROXIMATELY ONE DROP EVERY TWO SECONDS, WAS DETERMINED TO BE ORIGINATING FROM THE INSERTION SITE. THERE WAS NO SUSPECTED SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. AFTER DISCONTINUING THE INFUSION VIA THE PROXIMAL INFUSION PORT, THE LEAKAGE STOPPED IMMEDIATELY. NOTABLY, THE PATIENT'S RIGHT LEG (CATHETER INSERTION) WAS SWOLLEN WHEN COMPARED WITH THE LEFT LEG, AND THE CATHETER INSERTION SITE WAS SLIGHTLY RED AND SWOLLEN. AFTER INSPECTION, THE PHYSICIAN DECIDED TO REMOVE THE EXISTING CATHETER AND PLACE THE NEW ONE IN THE LEFT FEMORAL VEIN. AFTER REPLACING THE CATHETER, THE SWELLING GRADUALLY SUBSIDED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 22822203 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT RECEIVED IVTM THERAPY FOR FEVER MANAGEMENT. THE ICY CATHETER (LOT # 199200) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE ATTEMPT. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO THE IVTM TREATMENT. AFTER 38 HOURS OF TREATMENT, FOLLOWING THE REWARMING PHASE AT A RATE OF 0.25°C PER HOUR, THE THERMOGARD SYSTEM WAS SET TO FEVER MANAGEMENT MODE AT 37°C. AFTER THIS ADJUSTMENT, THE TARGET TEMPERATURE COULD NO LONGER BE SUSTAINED. THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), THE CATHETER WAS CHECKED FOR LEAKAGE AND SUBSEQUENTLY REMOVED. THE CUSTOMER SUSPECTED THE 250ML SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. TREATMENT WAS CONTINUED WITHOUT THE THERMOGARD SYSTEM. THE CONSOLE WAS VERIFIED TO BE FUNCTIONAL. THE CURRENT CONDITION OF THE PATIENT IS STABLE, SEDATED, AND VENTILATED. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476141 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT RECEIVED IVTM THERAPY FOR FEVER MANAGEMENT. THE ICY CATHETER (LOT#: 205971) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE ATTEMPT. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO THE IVTM TREATMENT. THE PATIENT'S BODY TEMPERATURE AT THE BEGINNING OF THE TREATMENT WAS 39.1 °C, AND THE TARGET TEMPERATURE WAS SET AT 37.5 °C TO COOL THE PATIENT. SEVENTY HOURS AFTER THE INITIATION OF THE TREATMENT (COOLING THE PATIENT), THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE ENTERED STANDBY MODE. THE CUSTOMER NOTICED THAT THE 500-ML SALINE BAG WAS EMPTY. NO SALINE SOLUTION WAS OBSERVED ON THE FLOOR, THE PATIENT'S BED, OR THE CONSOLE. THERE WAS NO BLOOD TINGE IN THE SUK TUBING. HOWEVER, THE CUSTOMER SUSPECTED THAT 250 ML OF SALINE HAD INFUSED INTO THE PATIENT'S BLOODSTREAM FROM THE CATHETER. THE CATHETER WAS REPLACED. THERE WERE NO ISSUES WITH THE THERMOGARD CONSOLE USED DURING THE EVENT. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023071 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY STARTED USING AN ICY CATHETER (LOT#: 194378). THE CATHETER WAS PLACED INTO THE LEFT FEMORAL VEIN SMOOTHLY ON THE FIRST ATTEMPT. PER THE REPORTER, SURFACE WARMING BAGS WERE USED ON THE PATIENT AS A TEMPERATURE MANAGEMENT METHOD BEFORE IVTM THERAPY. AFTER FOUR DAYS OF THERAPY, THE 500 ML SALINE BAG WAS NOTED EMPTY WITHIN SIX HOURS. AFTER INSPECTING THE CATHETER AND THE SUK FOR LEAKS, THE FIRST BAG WAS REPLACED; HOWEVER, THE SALINE LEVEL IN THE SECOND BAG STARTED DECREASING WITHIN TWO HOURS. THE CUSTOMER ESTIMATED THAT BETWEEN 600 AND 700 ML OF SALINE SOLUTION HAD BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM. THERE WERE NO SYSTEM ALARMS NOTED DURING THE TREATMENT AND THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. THE CATHETER WAS NOT REPLACED AND THE THERMOGARD CONSOLE WAS STOPPED. THE PATIENT WAS REPORTED TO BE IN A DIFFICULT CONDITION, BUT THERE WAS NO INJURY OR DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958784 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  APPROXIMATELY 36 HOURS AFTER THE ICY CATHETER (LOT # 195238) PLACEMENT, THE SALINE BAG WAS OBSERVED TO BE EMPTY. AS A RESULT, THERAPY WAS DISCONTINUED AND THE CATHETER WAS REMOVED. CLINICAL STAFF INSPECTED THE CATHETER, WITH NO EVIDENCE OF LEAKAGE IDENTIFIED. ADDITIONALLY, THE PATIENT'S BED, SURROUNDING FLOOR AREA, AND THE CATHETER INSERTION SITE WERE CHECKED AND ALL FOUND TO BE COMPLETELY DRY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958781 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY AFTER CARDIAC ARREST. THE ICY CATHETER (LOT # 209463) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE INSERTION ATTEMPT. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO THE IVTM THERAPY. THE PATIENT'S INITIAL BODY TEMPERATURE WAS 36.5°C, WITH A TARGET TEMPERATURE OF 34°C SET AT THE MAX COOLING RATE. APPROXIMATELY 25 MINUTES LATER, STAFF OBSERVED NO FLOW IN THE COOLING CIRCUIT. MANUAL FLUSHING ATTEMPTS WERE UNSUCCESSFUL. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER ICY (LOT # 209463) IN THE SAME INSERTION SITE. THE REMOVED CATHETER WAS FLUSHED AGAIN, BUT STILL WITHOUT SUCCESS. ABOUT 30 MINUTES AFTER USING THE SECOND ICY CATHETER, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. NO FLUID WAS VISIBLE IN THE BED. A CATHETER LEAK CHECK ACCORDING TO ZOLL IFU REVEALED A CATHETER LEAK. THE AMOUNT OF SALINE INFUSED INTO THE PATIENT'S BLOODSTREAM REMAINS UNKNOWN. THE SECOND CATHETER WAS THEN REMOVED AND REPLACED WITH A SOLEX 7 CATHETER. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. DURING THE CALL WITH THE ZOLL TECH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946158 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AT NOON ON (B)(6), PREPARATIONS WERE MADE TO INITIATE HYPOTHERMIA TREATMENT USING THE THERMOGARD XP IVTM SYSTEM. THE NURSE BEGAN PRIMING THE START-UP KIT (SUK) (LOT#: 208126) ACCORDING TO STANDARD PROCEDURES. HOWEVER, WHEN THE AIR TRAP HOLDER WAS POSITIONED AND THE PRIME SWITCH WAS HELD FOR OVER THREE MINUTES, THE SUK'S PINWHEEL DID NOT ROTATE AT ALL. THE DOCTOR DECIDED TO USE ANOTHER SUK, WHICH WAS SUCCESSFULLY PRIMED. THE ICY CATHETER (LOT#: 209536) WAS SUCCESSFULLY PLACED TO INITIATE THE HYPOTHERMIA TREATMENT. HOWEVER, THE DOCTOR IMMEDIATELY NOTICED BLOOD LEAKING FROM THE CATHETER'S ORANGE PORTS (BOTH IN AND OUT LUERS). IT WAS SUSPECTED THAT THE CATHETER'S BALLOON WAS LEAKING. THE ICY CATHETER AND SALINE BAG WERE REPLACED, AND THE PROCEDURE WAS INITIATED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905795 ↗
• MalfunctionApr 20, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS INITIATED USING AN ICY CATHETER (LOT# 198849). DURING THE THERAPY'S FEVER MODE, THE CONSOLE DISPLAYED AN AIR TRAP ALARM, AND THE SALINE BAG (WITH APPROX. 200ML) WAS FOUND TO BE EMPTY. CONSEQUENTLY, THE THERAPY WAS DISCONTINUED, THE CATHETER WAS REMOVED, AND NO ALTERNATIVE TEMPERATURE MANAGEMENT THERAPY WAS ADMINISTERED. ACCORDING TO THE REPORTER, THE CONSOLE REMAINS FULLY FUNCTIONAL AND READY FOR CLINICAL USE. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21870169 ↗
• MalfunctionApr 10, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT THE ICY CATHETER (LOT #195238) WAS RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819576 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE ICY CATHETER (LOT# 202910) WAS PLACED IN THE RIGHT FEMORAL VEIN. THE CATHETER WAS INSERTED SMOOTHLY, WITH NO REPORTED DIFFICULTIES. THE FOLLOWING DAY, WHEN THE CONSOLE WAS IN MAX POWER MODE, THE NURSE NOTED AN EMPTY 500 ML SALINE BAG. NO FLUID LEAKAGE WAS OBSERVED ON THE FLOOR, BED, OR CONSOLE, AND AROUND THE START-UP KIT (SUK) TUBING. ACCORDING TO THE REPORTER, THE CUSTOMER PERFORMED THE CATHETER LEAK TEST AND SUSPECTED THE CATHETER LEAK AND THE INFUSION OF 500 ML OF SALINE FLUID. THE CATHETER WAS REMOVED, AND A NEW CATHETER WAS PLACED TO RESUME THERAPY. ACCORDING TO THE REPORTER, THE PATIENT IS IN AN UNSTABLE CONDITION, WITH NO FURTHER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394221 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A 55-YEAR-OLD FEMALE PATIENT WHO HAD UNDERGONE CPR (BODY WEIGHT: 165 CM, 90 KG). AN ICY CATHETER (LOT #197210) WAS SMOOTHLY INSERTED INTO THE LEFT FEMORAL VEIN. AT THE BEGINNING OF THE IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS RECORDED AT 36°C, WITH A TARGET TEMPERATURE SET AT 36.8°C AT THE MAX RATE. DURING THE PROCEDURE, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP WARNING," AND AN EMPTY SALINE BAG WAS OBSERVED. THERE WERE NO SIGNS OF FLUID LEAKAGE ON THE THERMOGARD SYSTEM, PATIENT BED, OR FLOOR. THE CATHETER WAS THEN REMOVED, AND THERAPY WAS STOPPED. THE CATHETER HAD A DWELL TIME OF 60 HOURS. THE CUSTOMER REPORTED THAT ASPIRATING THE CATHETER WAS DIFFICULT, SO THEY CUT OFF THE ORANGE LUERS FROM THE CATHETER. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294470 ↗
• MalfunctionJan 28, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE HYPOTHERMIA PROCEDURE BEGAN ON (B)(6) WITH THE INSERTION OF AN ICY CATHETER (LOT # 201202) THROUGH THE RIGHT FEMORAL VEIN. THE CATHETER INSERTION WAS SMOOTH AFTER THE FIRST ATTEMPT. AROUND 9AM ON (B)(6) 2025, AN AIRTRAP ALARM ALERTED NURSES FOR A DECREASE OF SALINE IN THE BAG. INVESTIGATION REVEALED NO VISIBLE SPILLAGE ON THE FLOOR OR BED, BUT THE GAUZE AT THE CATHETER ACCESS SITE WAS SOAKED, CONTAINING WATERY BLOOD. THE PHYSICIAN SUSPECTED A LEAKAGE ISSUE WITH THE ICY CATHETER AND THE INFUSION OF THE 200 ML OF SALINE INTO THE PATIENT'S BLOODSTREAM AFTER THE PHYSICIAN PERFORMED THE CATHETER LEAK CHECK PER IFU. THE NEW ICY CATHETER WAS PLACED TO CONTINUE THE THERAPY WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249490 ↗