Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin CL-2295Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00849111075190), received between May 5, 2017 and Apr 6, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Fluid/Blood Leak; Material Integrity Problem

  PATIENT RECEIVING TARGETED TEMP MANAGEMENT VIA COOLGUARD IN LEFT SUBCLAV. WHILE IN ROOM, RN STARTED TO HEAR A DRIPPING SOUND, FOUND TO HAVE COOLGUARD ATTACHED TO "OUT" LUMEN, AND "IN" LUMEN FOUND SNAPPED OFF, W/ COOLGUARD SQUIRTING WATER INTO THE AIR. CHRONIC CARE MANAGEMENT CALLED TO BEDSIDE. COOLGUARD PLACED IN BIO BAG & AT BEDSIDE. COOLGUARD FLUID REMOVED FROM BALLOON & DISCHARGE PER CCM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795143 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN ICY CATHETER WAS USED ON A 70-YEAR-OLD MALE PATIENT AS PART OF A COOLING PROCEDURE INVOLVING THE THERMOGARD HQ SYSTEM. DURING USE, ON DAY 2, A LEAK FROM THE CATHETER BALLOON WAS OBSERVED. AS A RESULT, APPROXIMATELY 300 ML OF NORMAL SALINE GOT LEAKED AND INFUSED INTO THE PATIENT'S CIRCULATION. ANOTHER CATHETER WAS USED TO CONTINUE THE THERAPY. NO ADVERSE EFFECTS OR INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983084 ↗
• MalfunctionApr 17, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  COOLGUARD CVC(CENTRAL VENOUS CATHETER) BALLOON NOT INTACT. DRAINING NS BAG FROM COOLGUARD CVC LINE INTO PT. LINE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862248 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED A LEAKING COOL LINE CATHETER (LOT # UNKNOWN) AND THE INFUSION OF 200 ML OF SALINE. PER THE REPORTER, THE CATHETER INSERTION WAS SMOOTH, AND THE CATHETER WAS PLACED AFTER THE FIRST ATTEMPT. THE CATHETER LEAK WAS NOTED 9 DAYS AFTER CATHETER PLACEMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19815055 ↗
• MalfunctionJul 27, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  BEFORE INSERTING THE CATHETER INTO THE PATIENT, A BALLOON LEAK WAS DISCOVERED DURING THE COOL LINE CATHETER (LOT # 186498) BALLOON TEST. UNKNOWN IF THE CUSTOMER USED ANOTHER CATHETER TO START THE PROCEDURE OR IF AN ALTERNATIVE THERAPY WAS UTILIZED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409738 ↗
• MalfunctionMar 31, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT UNDERWENT IVTM THERAPY USING A THERMOGARD HQ TEMP MGT CONSOLE AND COOL LINE CATHETER (LOT # UNKNOWN). THE CATHETER WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. FIVE DAYS AFTER THE INITIATION OF THE TREATMENT, THE NURSE CALLED ZOLL AND REPORTED THAT THE 500-ML SALINE BAG WAS LEAKING, AND THE THERMOGARD SYSTEM HAD GENERATED AN "AIR TRAP" ALARM DURING THE NORMOTHERMIA PHASE OF THE TREATMENT. FOLLOWING THE ALARM, THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT TO STANDBY MODE. ZOLL CLINICAL FIELD SPECIALIST HELPED THE CUSTOMER TO TROUBLESHOOT THE ISSUE. THE NURSE INSPECTED THE START-UP KIT (SUK) TUBING CONNECTIONS FOR ANY LEAKAGE AROUND ITS ORANGE CONNECTION LUERS. ALSO, THE NURSE LOOKED UNDER THE PATIENT'S BODY TO SEE IF ANY FLUID WAS LEAKING OUT OF THE TUBING. THE BEDSIDE NURSE (RN) CONFIRMED THAT THERE WAS NO SALINE LEAKAGE FROM THE SUK TUBING. THE NURSE WAS INSTRUCTED TO DISCONNECT THE PATIENT FROM THE THERMOGARD SYSTEM AND HAD THE BEDSIDE RN FILL UP A SLIP-TIP SYRINGE WITH 10 ML OF STERILE SALINE. THE RN THEN CONNECTED THE SYRINGE TO THE "IN" PORT OF THE CATHETER WHILE HAVING THE "OUT" PORT REMAIN OPEN TO THE AIR. SALINE FLOWED OUT OF THE "OUT" PORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660557 ↗
• MalfunctionNov 23, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE IVTM THERAPY, A COOL LINE CATHETER (LOT # 175892) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. AFTER APPROXIMATELY 45 MINUTES OF THERAPY, THE CONSOLE GENERATED AN "AIR TRAP" ALARM AND THE NURSE OBSERVED A 500ML SALINE BAG EMPTY, THE SALINE WAS ALSO NOTED LEAKING FROM THE INSERTION SITE. PER THE REPORTER, THE INTRODUCER WAS PLACED IN THE SAME VEIN BEFORE THE CATHETER PLACEMENT. IN ADDITION, CATHETER INFUSION PORTS WERE UTILIZED DURING THE CATHETER USE, HOWEVER, THE REPORTER DOES NOT REMEMBER PARTICULAR PORTS THAT WERE USED. THE INFUSION OF THE 500ML OF SALINE FLUID AND THE CATHETER LEAK WAS SUSPECTED. THE NEW COOL LINE CATHETER WAS PLACED IN THE RIGHT SUBCLAVIAN VEIN 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 15858524 ↗
• MalfunctionSep 10, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY ON A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) FOR FEVER CONTROL, PATIENT WAS SUCCESSFULLY BEING MANAGED AT TARGET RANGES UNTIL THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER NOTICED BLOOD-TINGE BACKING UP IN START-UP KIT (SUK) TUBING, AND EMPTY1000ML SALINE BAG. THE SUK AND SALINE BAG WERE REPLACED, PRIMED AND HOOKED TO PATIENT, BLOOD-TINGE WAS NOTICED AGAIN IN THE SUK TUBING. THE CUSTOMER TRIED TO RUN THE THERMOGARD IVTM SYSTEM A FEW TIMES BUT WAS UNSUCCESSFUL DUE TO "AIR TRAP WARNING" ALARMS. THE CUSTOMER REMOVED COOL LINE CATHETER (LOT #172802) FROM THE PATIENT'S LEFT SUBCLAVIAN VEIN AND OBSERVED INTERNAL BALLOONS APPEARED RUPTURED. A EXPERIENCED PHYSICIAN ATTEMPTED TO INSERT A NEW COOL LINE CATHETER OVER GUIDEWIRE BUT WAS UNSUCCESSFUL, AS THE CATHETER COULD NOT GET TO THREAD INTO THE PATIENT. ANOTHER TEMPERATURE MANAGEMENT WAS UTILIZED TO CONTINUE WITH TREATMENT. THERE WAS NO POWER INJECTION, RAPID TRANSFUSION, OR OTHER LINES IN SAME INSERTION SITE. IT IS UNKNOWN HOW MUCH SALINE WAS INFUSED INTO THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR (B)(4) FOR THETHERMOGARD IVT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397492 ↗
• MalfunctionJun 17, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) UNDERWENT IVTM THERAPY TO MAINTAIN NORMOTHERMIA. A COOL LINE CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S LEFT SUBCLAVIAN VEIN WITH NO ISSUES. IT WAS REPORTED THAT THE CUSTOMER POTENTIALLY POWERED INJECTED CONTRAST THROUGH THE CENTRAL LINE ACCESS. FOUR DAYS AFTER THE INITIATION OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE STAFF NOTICED THAT THE 500-ML SALINE BAG HAD RUN EMPTY. THE STAFF REPLACED THE SALINE BAG AND RESUMED THE TREATMENT. THE CUSTOMER DID NOT PERFORM A CATHETER LEAK CHECK PER THE ZOLL'S NEW IFU BEFORE REPLACING THE SALINE BAG. AFTER ABOUT 3 TO 4 HOURS, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM AGAIN. THE STAFF NOTICED THAT THE SECOND SALINE BAG WAS ALSO RUNNING EMPTY. IN ADDITION, THE STAFF OBSERVED BLOOD-TINGED SALINE IN THE START-UP KIT (SUK) TUBING, AN INDICATION OF A CATHETER LEAK. AN UNKNOWN AMOUNT OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM IS SUSPECTED. THE STAFF PLACED THE CONSOLE INTO STANDBY MODE AND REMOVED THE CATHETER. THE IVTM THERAPY WAS NOT RESUMED, AND NO OTHER TEMPERATURE MANAGEMENT DEVICES WERE USED, AS THE PATIENT NO LONGER NEEDED TEMPERATURE CONT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739602 ↗
• InjuryApr 8, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, CUSTOMER NOTICED THE THERMOGARD IVTM SYSTEM (SN UNKNOWN) HAD ALARMED AND THE SALINE BAG WAS NEARLY EMPTY AND THAT THE LINEN WAS WET. CUSTOMER SUSPECTED A ICY CATHETER (LOT #UNKNOWN) BALLOON LEAK. THE CATHETER WAS FLUSHED WITHOUT RESISTANCE AND NO BLOOD WAS NOTED. THEY REMOVED THE CATHETER AND PLACED A SOLEX 7 AND CONTINUED THERAPY. PRIOR TO WHEN ISSUE NOTICED, THE PATIENT HAD REACHED THE TARGET TEMPERATURE AND THE THERMOGARD CONSOLE MAINTAINED ITS TARGET TEMPERATURE SETTING. PER REPORTER, THE PATIENT'S THIGH WAS A LITTLE SWOLLEN. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00423 FOR THE THERMOGARD IVTM SYSTEM (SN UNKNOWN).

  Patient problems: Inflammation

  MAUDE report 14057537 ↗
• MalfunctionMar 22, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY ON A (B)(6) YEARS OLD FEMALE ADMITTED FOR AN INTRACEREBRAL ANEURYSM AND HAD A CARDIAC ARREST DURING AN EARLIER SURGERY. THE INSERTION OF THE COOL LINE CATHETER WAS SMOOTH IN THE PATIENT'S LEFT FEMORAL VEIN. A DAY AFTER TREATMENT WAS INITIATED, SALINE FLUID WAS NOTICED ON A LAID DISPOSABLE PAD WHERE THE LUER CONNECTION OF THE COOL LINE CATHETER (LOT #UNKNOWN) AND THE START-UP KIT (SUK) (LOT #UNKNOWN) SAT ON THE PATIENT'S BED. THE NURSE REPORTED THAT THE ZOLL CATHETER OR START-UP KIT TUBING LEAKING ONTO THE BED OVERNIGHT AND STILL LEAKING IN THE MORNING. ONE SALINE BAG HAD BEEN CHANGED OVERNIGHT DUE TO GOING EMPTY. DURING THE REPORTED LEAKING, THE PATIENT HAD NO ISSUES MAINTAINING TARGET TEMPERATURE WITH THE THERMOGARD CONSOLE. ZOLL CLINICAL FIELD SPECIALIST (CFS) WAS ON THE CUSTOMER SITE AT THE TIME OF THE REPORTED EVENT AND EXAMINED THE CATHETER, SUK AND SALINE BAG, FOUND NO LEAK OR BREECH. THEN, THE ZOLL CFS LOCKED THE CONNECTION BETWEEN THE CATHETER AND THE SUK AND RESTARTED THE THERMOGARD CONSOLE, NO LEAK WAS OBSERVED FROM THE LUERS/CONNECTION AREA. THE CATHETER BALLOONS WERE DEFLATED/INFLATED , AND NO BLOOD WAS OBSERVED. THE SUK APPEARED NORMAL WITH NO BRE

  Patient problems: Insufficient Information

  MAUDE report 13849240 ↗
• MalfunctionNov 30, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON 05 NOVEMBER 2021, ZOLL RECEIVED A MEDWATCH REPORT MW5103252: PT HAS COOLGARD CENTRAL LINE TRIPLE LUMEN IN THE LEFT FEMORAL SITE. DURING SHIFT RN SPARKS OBSERVED THE NORMAL SALINE BAG ATTACHED TO THE COOLGARD SET UP HAD LESS SALINE IN 1T THAN USUAL. RESIDENT AND ATTENDING PHYSICIANS WERE MADE AWARE AS WAS THE FAMILY OF PT. DECISION MADE TO REMOVE DEFECTIVE COOLGARD CATHETER AND PLACE A NEW ONE. AROUND 350-400 ML'S INFUSED INTO THE PATIENTS FEMORAL CATHETER DUE TO A FAULTY BALLOON IN COOLGARD CATHETER SYSTEM. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 12903644 ↗
• InjuryAug 26, 2021Use of Device Problem; Use of Device Problem

  A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) WAS HOSPITALIZED IN CRITICAL CONDITION TO RECEIVE IVTM THERAPY. THE COOL LINE CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN VEIN. THE CUSTOMER WAS UNABLE TO FLUSH THE TWO INFUSION PORTS AND COULD NOT DRAW BACK BLOOD. IN ADDITION, THE CUSTOMER REPORTED THAT THE ORANGE PORTS (IN/OUT LUERS) WERE BLOCKED/OBSTRUCTED. EVEN AFTER SWITCHING THE THERMOGARD SYSTEM MULTIPLE TIMES, SALINE WAS NOT PROPERLY CIRCULATING IN THE TUBING. ON THE THIRD DAY OF THE TREATMENT, ANOTHER COOL LINE CATHETER (LOT # UNKNOWN) WAS PLACED IN THE PATIENT'S SUBCLAVIAN VEIN. AS REPORTED, PNEUMOTHORAX WAS NOTICED AFTER THE INSERTION OF THE SECOND COOL LINE CATHETER. THE PNEUMOTHORAX WAS TREATED WITH A CHEST TUBE PLACED TO SUCTION. THE IVTM TREATMENT WAS CONTINUED AND COMPLETED WITH THE SECOND COOL LINE CATHETER. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00762 FOR THE COOL LINE CATHETER (LOT # UNKNOWN).

  Patient problems: Pneumothorax

  MAUDE report 12375473 ↗
• InjuryAug 26, 2021Use of Device Problem; Use of Device Problem

  A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) WAS HOSPITALIZED IN CRITICAL CONDITION TO RECEIVE IVTM THERAPY. THE COOL LINE CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN VEIN. THE CUSTOMER WAS UNABLE TO FLUSH THE TWO INFUSION PORTS AND COULD NOT DRAW BACK BLOOD. IN ADDITION, THE CUSTOMER REPORTED THAT THE ORANGE PORTS (IN/OUT LUERS) WERE BLOCKED/OBSTRUCTED. EVEN AFTER SWITCHING THE THERMOGARD SYSTEM MULTIPLE TIMES, SALINE WAS NOT PROPERLY CIRCULATING IN THE TUBING. ON THE THIRD DAY OF THE TREATMENT, ANOTHER COOL LINE CATHETER (LOT # UNKNOWN) WAS PLACED IN THE PATIENT'S SUBCLAVIAN VEIN. AS REPORTED, PNEUMOTHORAX WAS NOTICED AFTER THE INSERTION OF THE SECOND COOL LINE CATHETER. THE PNEUMOTHORAX WAS TREATED WITH A CHEST TUBE PLACED TO SUCTION. THE IVTM TREATMENT WAS CONTINUED AND COMPLETED WITH THE SECOND COOL LINE CATHETER. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00820 FOR THE COOL LINE CATHETER (LOT # UNKNOWN).

  Patient problems: Pneumothorax

  MAUDE report 12375442 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem; Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem

  A (B)(6) Y.O. PATIENT EXPERIENCED INTRAPARENCHYMAL HEMORRHAGE AND WAS ADMITTED. IVTM THERAPY WAS USED TO PREVENT NEUROGENIC FEVER. AFTER 7 DAYS OF IVTM THERAPY, THE THERMOGARD IVTM SYSTEM (SERIAL #UNKNOWN) GENERATED AN AIR TRAP ALARM. THE HOSPITAL STAFF OBSERVED BLOOD ON THE START-UP KIT (SUK) AND ALSO NOTICED THE 500ML NORMAL SALINE (NS) BAG WAS EMPTY. IVTM THERAPY WAS STOPPED AND THERMOGARD SYSTEM WAS PLACED ON STANDBY. WHILE THE COOL LINE CATHETER (LOT#149663) WAS BEING PULLED OUT, IT GOT STUCK HALF WAY. COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND NEGATIVE FOR CONTRAINDICATIONS AND CATHETER WAS SUCCESSFULLY REMOVED. PER REPORTER, THE COOL LINE CATHETER WAS INTACT AND BALLOONS WERE SEPARATED, BUT CONNECTED TO THE CATHETER WHEN REMOVED, NO SIGN OF MISSING BALLOON PIECES. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00282 FOR THE THERMOGARD IVTM SYSTEM (SN UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468217 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING IVTM THERAPY, THE PATIENT WAS INSERTED WITH A COOL LINE CATHETER. AFTER AN UNKNOWN PERIOD, THE CUSTOMER NOTICED THE BLOOD BACKING UP IN THE TUBING. THE CATHETER LEAK AND 500 ML OF SALINE INFUSION WERE SUSPECTED. THE REPORTER DID NOT PROVIDE INFORMATION IF THE CATHETER WAS REPLACED OR ALTERNATIVE THERAPY WAS UTILIZED. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE USER WILL NOT RETURN THE COOL LINE CATHETER AS IT WAS DISPOSED OF ON-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389332 ↗
• MalfunctionOct 2, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT WAS ADMITTED FOR FEVER CONTROL TREATMENT USING IVTM THERAPY. A COOL LINE CATHETER (LOT# 146259) WAS INSERTED INTO THE PATIENT'S LEFT JUGULAR VEIN, WITH NO UNUSUAL RESISTANCE NOTED. NO OTHER CENTRAL LINE WAS PLACED AFTER THE COOL LINE CATHETER WAS INSERTED. AFTER ABOUT 70 HOURS, DURING THE MAINTENANCE PHASE, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM, AND THE NURSE NOTICED THAT THE 500 ML SALINE BAG WAS EMPTY. THERE WERE NO TRACES OF FLUID OBSERVED ON THE THERMOGARD CONSOLE, PATIENT'S BED, OR FLOOR. CATHETER LEAK AND INFUSION OF ABOUT 500 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. SINCE THE PATIENT DID NOT NEED FURTHER TREATMENT, THE CATHETER WAS REMOVED, AND THE THERAPY WAS ENDED. NO DEVICE MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10623749 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE PHYSICIAN PLACED A FIRST COOL LINE CATHETER (LOT # 96693) INTO PATIENT'S SUBCLAVIAN VEIN. THE USER OBSERVED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE PHYSICIAN REPLACED THE FIRST COOL LINE CATHETER WITH THE SECOND COOL LINE CATHETER (LOT # 96693) AND OBSERVED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. SUSPECTING CATHETER BALLOON BREACH. THE IVTM TREATMENT WAS DISCONTINUED AND THE PATIENT TREATMENT WAS CONTINUED WITH AN ALTERNATE TEMPERATURE MANAGEMENT METHOD. PER USER, THE PHYSICIAN CHOSE TO USE THE COOL LINE CATHETER BECAUSE THE PATIENT HAD WOUNDS IN THE GROIN, AND THE HOSPITAL DOES NOT HAVE SOLEX CATHETER. NO DEVICE MALFUNCTION WAS REPORTED FOR THE THERMOGARD XP IVTM SYSTEM. NO PATIENT CONSEQUENCE WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2020-00082 FOR THE SECOND COOL LINE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9645193 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE PHYSICIAN PLACED A FIRST COOL LINE CATHETER (LOT # 96265) INTO PATIENT'S SUBCLAVIAN VEIN. THE USER OBSERVED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE PHYSICIAN REPLACED THE FIRST COOL LINE CATHETER WITH THE SECOND COOL LINE CATHETER (LOT # 96265) AND OBSERVED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. SUSPECTING CATHETER BALLOON LEAK. THE IVTM TREATMENT WAS DISCONTINUED AND THE PATIENT TREATMENT WAS CONTINUED WITH AN ALTERNATE TEMPERATURE MANAGEMENT METHOD. PER USER, THE PHYSICIAN CHOSE TO USE THE COOL LINE CATHETER BECAUSE THE PATIENT HAD WOUNDS IN THE GROIN, AND THE HOSPITAL DOES NOT HAVE SOLEX CATHETER. NO DEVICE MALFUNCTION WAS REPORTED FOR THE THERMOGARD XP IVTM SYSTEM. NO CONSEQUENCES OR IMPACT TO THE PATIENT WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2020-00081 FOR THE FIRST COOL LINE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9645192 ↗
• MalfunctionDec 27, 2017Leak/Splash; Leak/Splash

  A PATIENT WHO SUSTAINED A TOTAL BODY SURFACE AREA (TBSA) BURN TRAUMA WAS INSERTED A COOL LINE CATHETER FOR IVTM TREATMENT. ON DAY 2 OF IVTM TREATMENT, THE HOSPITAL NURSE REPORTEDLY OBSERVED THAT THE FLUID LEVEL IN THE SALINE BAG EMPTIED. IT WAS NOTED THAT DURING THIS TIME, THE TARGET PATIENT TEMPERATURE WAS ACHIEVED AND HAD BEEN MAINTAINED. UPON INSPECTION, NO PHYSICAL SIGNS OF LEAK ON THE PATIENT'S BEDSIDE OR ON THE FLOOR WAS REPORTED. NO ALARM WAS OBSERVED ON THE CONSOLE. A CATHETER LEAK WAS SUSPECTED, AND THE COOL LINE CATHETER WAS REMOVED. AS TARGET TEMPERATURE HAD BEEN ACHIEVED AND MAINTAINED, THE IVTM TREATMENT WAS DISCONTINUED. FURTHER INFORMATION FROM THE CLINICAL SPECIALIST STATED THAT THE PATIENT EXPIRED A FEW DAYS AFTER, THE CAUSE OF THE OUTCOME WAS ATTRIBUTED TO MULTIPLE TRAUMA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149914 ↗
• MalfunctionNov 6, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED AND AN INTRAVASCULAR TEMPERATURE MANAGEMENT WAS NEEDED FOR FEVER MANAGEMENT. A ZOLL COOL LINE CATHETER WAS INSERTED INTO THE SUBCLAVIAN VEIN. THE INDWELL TIME OF THE CATHETER WAS THREE DAYS. THE ATTENDING NURSE NOTED BLOOD COMING BACK UP INTO THE CIRCULATING PORTS OF THE COOL LINE. THE CATHETER WAS REPLACED TO CONTINUE WITH THE TREATMENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003833 ↗
• MalfunctionSep 6, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED DUE TO FEVER AND LARGE VOLUME MULTICOMPETENT INTRACRANIAL HEMORRHAGE AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A ZOLL COOL LINE CATHETER WAS INSERTED INTO THE LEFT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. THREE DAYS AFTER THE TREATMENT WAS INITIATED, BLOOD WAS NOTED IN THE CATHETER. THE CATHETER WAS REMOVED AND BLANKET WAS APPLIED TO THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6847227 ↗
• MalfunctionMay 5, 2017Leak/Splash; Leak/Splash

  A FEMALE PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND UNDERWENT TREATMENT FOR HYPOTHERMIA. AT THE START OF THE THERAPY. UPON STARTING THE COOLING, BLOOD WAS NOTED IN THE STARTUP KIT (SUK) AND AIR TRAP ALARM WENT OFF. THE SALINE BAG WAS OBSERVED TO BE EMPTY. THE COOL LINE CATHETER WAS REPLACED AND THE THERAPY WAS REINITIALIZED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6549436 ↗