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

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00849111075046), received between Mar 2, 2016 and Oct 13, 2022 — classified as 1 death, 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED ONLY 50 CC OF SALINE REMAINED IN THE NS BAG. UPON TROUBLESHOOTING, IT WAS DETERMINED THAT THE COOL LINE CATHETER (LOT #UNKNOWN) HAS A BALLOON LEAK. THE CATHETER WAS PLACED IN THE SUBCLAVIAN VEIN AND WAS CONTINUED TO BE USED ONLY AS A CENTRAL LINE. THE CATHETER WAS DISCONNECTED DURING DAY SHIFT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 15592879 ↗
• MalfunctionJan 15, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE COOL LINE CATHETER (LOT # UNKNOWN) WAS USED TO PROVIDE IVTM TREATMENT. PER THE REPORTER, THE CATHETER INSERTION WAS SMOOTH. THE THERAPY CONTINUED FOR TWO DAYS WITHOUT ISSUES. DURING THE NORMOTHERMIA, AFTER THE PATIENT WAS REWARMED, THE NURSE NOTICED A SMALL AMOUNT OF BLOOD IN THE SUK TUBING NEAR THE ORANGE LUERS. THERE WERE NO EXTERNAL LEAKS AND NO ISSUE WITH THE SUK WAS REPORTED. THERE WAS NO ALARM GENERATED BY THE CONSOLE AS THE SALINE BAG HAD NOT DEPLETED YET AND THE NURSE NOTICED A MINIMAL AMOUNT OF BLOOD. THE CATHETER LEAK WAS SUSPECTED. PER THE CUSTOMER, THEY HAD NOT USED THE CATHETER FOR POWER INJECTION AND HAD NO ISSUES WITH THE CONSOLE. THE CUSTOMER WAS INSTRUCTED TO REPLACE THE CATHETER, HOWEVER, THE NEW CATHETER WAS NOT PLACED AS THE PATIENT WAS REWARMED TO THE TARGET TEMPERATURE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262522 ↗
• MalfunctionJan 13, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, CUSTOMER NOTICED BLOOD TINGE IN THE START-UP KIT (SUK) TUBING CONNECTING THE THERMOGARD IVTM SYSTEM TO THE COOL LINE CATHETER. THE PATIENT WAS NOT REACHING THE TARGET TEMPERATURE AT 36 DEGREES, PATIENT TEMPERATURE STAYED AT 36.5 DEGREES. THE COOL LINE CATHETER (LOT #UNKNOWN) SUSPECTED TO BE LEAKING. THE CUSTOMER PLACED THE THERMOGARD IVTM SYSTEM ON STANDBY AND PER REPORTER, THE CONSOLE IS FUNCTIONING PROPERLY. THE CATHETER IN QUESTION WAS REMOVED FROM THE PATIENT SUBCLAVIAN VEIN AND ICE PACKS WAS USED TO CONTINUE WITH TREATMENT. PER REPORTER, WHEN SLIP TIP SYRINGE WAS APPLIED TO ORANGE LUER AND ASPIRATED, BLOOD WAS NOTED IN THE SYRINGE INDICATES A POTENTIAL CATHETER LEAK. NO OTHER LINES WERE PLACED NEAR THE COOL LINE CATHETER. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256421 ↗
• MalfunctionDec 21, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, IT WAS NOTED THAT BLOOD TINGED WAS OBSERVED WITHIN THE CLOSED LOOPED OF THE START-UP KIT (LOT #167955). COOL LINE CATHETER (LOT #162889) SUSPECTED TO BE LEAKING. THE CATHETER AND SUK WERE REPLACED AND TREATMENT CONTINUED WITH THE SAME CONSOLE. PER HOSPITAL'S PHYSICIANS, THE CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S SUBCLAVIAN VEIN. NO POWER INJECTION OCCURRED, NO RAPID TRANSFUSION OCCURRED THROUGH LINE AND NO OTHER LINES NOTED WITHIN THE SAME VESSEL. CATHETER DWELL TIME WAS 2 DAYS. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 13054707 ↗
• DeathAug 24, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS HOSPITALIZED POST-CARDIAC ARREST IN THE FIELD AFTER THE MOTORCYCLE ACCIDENT WITH THE TRAUMATIC BRAIN INJURY (TBI). THE COOL LINE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. DURING THE IVTM THERAPY, THE USER OBSERVED AN EMPTY SALINE BAG DUE TO THE CATHETER LEAK. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT WAS DIAGNOSED AS BRAIN DEAD.

  Patient problems: Brain Injury

  MAUDE report 12363563 ↗
• MalfunctionAug 21, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY FOR A (B)(6) PATIENT USING A COOL LINE CATHETER (LOT #151932), THE USER OBSERVED AN EMPTY SALINE BAG AND NOTICED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE USER REPORTED A CATHETER LEAK AND APPROXIMATELY 500 ML OF SALINE INFUSION INTO THE PATIENT BODY. THE COOL LINE CATHETER WAS REMOVED FROM THE PATIENT, AND THE SPECIFICS OF FURTHER OR ALTERNATIVE TREATMENT WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351833 ↗
• MalfunctionAug 20, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, IT WAS NOTED THAT BLOOD WAS OBSERVED IN THE START-UP KIT (SUK) AND THE SALINE BAG HAD DECREASED. THE THERMOGARD CONSOLE (SERIAL #UNKNOWN) GENERATED AN ALARMED. THE CATHETER PLACEMENT WAS INTO THE PATIENT'S FEMORAL VEIN. THE COOL LINE CATHETER (LOT #UNKNOWN) SUSPECTED TO BE LEAKING AND IT WAS REMOVED. A NEW CATHETER WAS PLACED TO CONTINUE WITH THERAPY. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2021-00814 FOR THERMOGARD CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349537 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CATHETERIZATION FOR A CRITICALLY ILL PATIENT WITH CLOTTING ISSUES, THE TRAUMA SURGEON EXPERIENCED DIFFICULTY WHILE TRYING TO PLACE A COOL LINE CATHETER (LOT # UNKNOWN) INTO THE PATIENT'S SUBCLAVIAN VEIN. THE PATIENT HAD SOME HEMATOMAS ON THE SITE AFTER THE SURGEON TRIED INSERTION ATTEMPTS TO PLACE THE COOL LINE CATHETER. AFTER FEW ATTEMPTS, THE SURGEON DECIDED TO PLACE A QUATTRO CATHETER (LOT # UNKNOWN) INTO THE PATIENT'S FEMORAL VEIN AND WAS ABLE TO PLACE THE CATHETER SUCCESSFULLY TO TREAT THE PATIENT. IN ADDITION, THE SURGEON REPORTED GUIDEWIRE (LOT # UNKNOWN) BEING "FLIMSY." PER THE CUSTOMER, THERE WAS NO DEVICE MALFUNCTION ON THE CATHETERS.

  Patient problems: Hematoma

  MAUDE report 11469094 ↗
• MalfunctionAug 8, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING PATIENT TREATMENT FOR FEVER CONTROL, THE COOL LINE CATHETER WAS PLACED IN THE JUGULAR VEIN. AFTER 5 HOURS OF THE TREATMENT, THE USER OBSERVED AN EMPTY SALINE BAG AND THE CONSOLE GENERATED AN AIR TRAP ALARM. THE AIR TRAP ALARM WAS CLEARED AND A NEW SALINE BAG WAS PLACED, HOWEVER, THE SALINE LEVEL DECREASED AGAIN. THE CUSTOMER WAS ADVISED TO CHANGE THE START-UP KIT (SUK), BUT THE ISSUE PERSISTED WITH THE NEW SUK AS WELL. THE CUSTOMER DISCONTINUED THE USE OF IVTM THERAPY AND AN ALTERNATIVE METHOD WAS USED TO COMPLETE PATIENT TREATMENT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876760 ↗
• MalfunctionFeb 27, 2019Use of Device Problem; Use of Device Problem

  DURING IVTM THERAPY, CUSTOMER REPORTED THAT BALLOONS LEAKAGES WERE OBSERVED ON THE ICY CATHETER (LOT #UNKNOWN) AND COOL LINE CATHETER (LOT #UNKNOWN). NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375005 ↗
• MalfunctionFeb 22, 2019Use of Device Problem; Use of Device Problem

  DURING PATIENT IVTM THERAPY, CUSTOMER REPORTED LEAK ON THE COOL LINE CATHETER (LOT # UNKNOWN). CUSTOMER NOTICED SALINE LEVEL DROPPING DURING THE COURSE OF TREATMENT AND THAT THEY STARTED WITH 1000ML BAG AND THERE WAS ONLY 300ML LEFT. THERE WAS NO SALINE FOUND NEAR THE PATIENT, BED NOR ON THE FLOOR. NOTE THAT THE COOL LINE CATHETER WAS INSERTED SMOOTHLY INTO THE PATIENT'S RIGHT FEMORAL VEIN. NO PATIENT IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363873 ↗
• MalfunctionFeb 5, 2019Use of Device Problem; Use of Device Problem

  DURING HYPOTHERMIA THERAPY, THE COOLLINE CATHETER WAS OBSERVED WITH BLOOD ON THE CATHETER TUBING. THE NURSE REPORTED A "BALLOON RUPTURE" ON THE CATHETER. NO FURTHER PATIENT INFORMATION RECEIVED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308565 ↗
• MalfunctionApr 26, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE PATIENT WAS INSERTED A COOLLINE CATHETER IN THE INTERNAL JUGULAR VEIN WITHOUT ANY REPORTED ISSUE AND RECEIVED IVTM THERAPY. PER REPORT, ON DAY 6 THE USER OBSERVED THAT THE FLUID LEVEL OF THE SALINE BAG WAS EMPTYING. NO SIGNS OF LEAK ON THE SUK OR ON THE PATIENT'S BEDSIDE WAS OBSERVED. THE USER DECIDED TO REPLACE THE SALINE BAG; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. A CATHETER LEAK WAS SUSPECTED. FOLLOWING THIS, IVTM THERAPY WAS DISCONTINUED AS THE PATIENT HAD ALREADY ACHIEVED TARGET REWARMING TEMPERATURE. THE COOL LINE CATHETER WAS REMOVED WITHOUT ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7467397 ↗
• MalfunctionDec 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MALE PATIENT WEIGHING (B)(6) KG WAS HOSPITALIZED ON (B)(6) 2017 WITH HEAD TRAUMA AND UNDERWENT TREATMENT FOR FEVER CONTROL. COOL LINE CATHETER WAS INSERTED INTO THE INTERNAL JUGULAR VEIN OF THE PATIENT TO BEGIN TREATMENT. TREATMENT WAS FINISHED FOUR DAYS LATER ((B)(6) 2017) BUT THE COOL LINE CATHETER WAS NOT REMOVED AND THE CHEMICAL-INFUSION LUMEN WAS USED AS A CV CATHETER. NEXT DAY, (B)(6) 2017, THE CHEMICAL (PROPOFOL) WAS FOUND TO BE LEAKING FROM THE CATHETER INSERTION POINT AND LEAK COULD NOT BE STOPPED. THE CATHETER WAS REMOVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153340 ↗
• MalfunctionDec 11, 2017Leak/Splash; Device Issue; Leak/Splash; Device Issue

  A MEDWATCH REPORT (NO REFERENCE NUMBER) WAS RECEIVED BY THE MANUFACTURER VIA POSTAL MAIL ON 04 DEC 2017. THE REPORTED EVENT STATES A SUSPECTED LEAK ON THE INSERTED COOL LINE CATHETER (LOT 63082). PER REPORT, RUPTURED BALLOON AND BLOOD ON THE CATHETER TUBING WERE OBSERVED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105668 ↗
• MalfunctionAug 9, 2017Leak/Splash; Leak/Splash

  THE PATIENT WAS INSERTED A COOL LINE CATHETER AND ACHIEVED NORMOTHERMIA ON DAY 4 OF IVTM THERAPY; HOWEVER, THE HOSPITAL PERSONNEL OBSERVED THAT THE SALINE BAG WAS EMPTY. NO PHYSICAL SIGNS OF LEAK WAS OBSERVED ON THE FLOOR AND ON THE PATIENT'S BEDSIDE. AFTER CATHETER REMOVAL, FLUID WAS REPORTEDLY OBSERVED TO BE LEAKING OUT OF THE CATHETER ALTHOUGH THE REPORTER WAS UNABLE TO IDENTIFY THE SPECIFIC SITE OF THE LEAK WITHIN THE CATHETER. NO ADJUNCTIVE TEMPERATURE MANAGEMENT WAS PERFORMED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6777766 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PREGNANT PATIENT WHO WAS POLYTRAUMATIZED (TRAUMATIC SUBARACHNOID HEMORRHAGE AND DIFFUSED CEREBRAL CONTUSION) AS A RESULT OF AN AUTOMOBILE ACCIDENT WAS HOSPITALIZED. PATIENT COMORBIDITY WERE AS FOLLOWS: BILATERAL HEMOPNEUMOTHORAX, MULTIPLE FRACTURED RIBS, CLAVICLES, SCAPULAE, LUNG INJURY, LIVER INJURY. THE PATIENT, DURING HOSPITALIZATION, RECEIVED IVTM TREATMENT ON (B)(6) 2017 USING A COOL LINE CATHETER INSERTED IN THE RIGHT FEMORAL VEIN. FEVER CONTROL WAS PERFORMED USING THE IVTM FOR SEVEN DAYS AND COMPLETED ((B)(6) 2017). THE IVTM SYSTEM PERFORMED AS INTENDED WITHOUT ANY ISSUES. ACCORDING TO THE PHYSICIAN, HEPARIN WAS NOT ADMINISTERED DURING IVTM TREATMENT AS THE PATIENT WAS POLYTRAUMATIZED AND BLEEDING AT THAT TIME. ADDITIONAL INFORMATION RECEIVED STATED THAT ON (B)(6) 2017, AN ECHOCARDIOGRAM WAS PERFORMED AND THROMBUS WAS FOUND IN THE INFERIOR VENA CAVA. HEPARIN ANTI-COAGULANT TREATMENT WAS ADMINISTERED. ON (B)(6) 2017, DISAPPEARANCE OF THE THROMBUS WAS CONFIRMED. ON (B)(6) 2017, THE PATIENT SUFFERED A HEMORRHAGIC SHOCK. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) WAS PERFORMED FOR LEFT ILIOPSOAS MUSCLE BLEEDING. THE FETAL DEATH IN UTERO WAS CONFIRMED. NO FU

  Patient problems: Thrombosis

  MAUDE report 6675559 ↗
• MalfunctionApr 6, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND UNDERWENT TREATMENT FOR HYPOTHERMIA ON (B)(6) 2017. A WEEK AFTER THE TREATMENT WAS INITIATED, THE NURSE FOUND BLOOD THAT ENTERED ABOUT HALF WAY INTO THE START-UP KIT (SUK) TUBE. THE NURSE CLAMPED DOWN THE TUBE AND AS SOON AS THE PHYSICIAN RECEIVED THE REPORT FROM THE NURSE, THE COOL LINE CATHETER WAS REMOVED. THE PHYSICIAN BELIEVES THERE WAS NO HEALTH DAMAGE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6464577 ↗
• MalfunctionSep 2, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CUSTOMER PLACED A COOL LINE CATHETER WITH THE NEW ORANGE ZOLL LUERS IN A NEURO PATIENT ((B)(6) MALE PATIENT WEIGHING (B)(6) AND 6' 2'' IN HEIGHT) TO HELP MAINTAIN NORMOTHERMIA/FEVER CONTROL ON (B)(6) 2016. THE PATIENT HAS A MEDICAL HISTORY OF MIGRAINES AND WAS DIAGNOSED FOR NON-TRAUMATIC INTRACRANIAL HEMORRHAGE. ON (B)(6) 2016, NURSE TRIED TO HOOK THE PATIENT BACK UP TO THE IVTM CONSOLE AFTER HE RETURNED FROM A PROCEDURE AND FOUND THE ORANGE LUER TO BE HARD TO CONNECT AND THEN A STEADY STREAM OF FLUID COMING FROM ORANGE LUER WHEN IT WAS HOOKED UP. THE NURSE TURNED OFF THE CONSOLE. THE CLINICAL SPECIALIST CONFIRMED THAT PROBLEM REPORTEDLY WAS OCCURRING WITH THE ORANGE LUER. IT IS UNKNOWN IF THE PROBLEM WAS WITH LUERS OF CATHETER OR START-UP KIT (SUK). NO HARM HAD OCCURRED TO THE PATIENT. THE PHYSICIAN REMOVED THE CATHETER AND USED COOLING BLANKETS TO MAINTAIN NORMOTHERMIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5926519 ↗
• MalfunctionJul 20, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT COOL LINE CATHETER WAS INSERTED IN A LEFT SUBCLAVIAN OF A MALE PATIENT ((B)(6)), THE INSERTION WAS DIFFICULT. THREE PUNCTURES WERE MADE. ONE COMPLICATION WAS SUBCLAVIAN ARTERIAL PUNCTURE PRIOR TO GETTING CORRECT PLACEMENT. NO WATER WAS NOTED ON PATIENT OR AROUND THERMOGARD. PINHOLE LEAK LIKELY OCCURRED TO BALLOON. IT WAS INSTRUCTED TO CHANGE CATHETER OVER GUIDEWIRE. THE CATHETER WAS PLACED IN PATIENT FOR 6 DAYS. THE AIRTRAP CHAMBER ALARM WAS NOTICED DURING THERAPY. PATIENT IS IN A STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5809474 ↗
• MalfunctionMay 24, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT (B)(6) MALE PATIENT WAS BEING TREATED WITH COOL LINE CATHETER FOR FEVER MANAGEMENT. CATHETER WAS INSERTED SMOOTHLY INTO RIGHT SUBCLAVIAN VEIN. ON SIXTH DAY OF THE TREATMENT, NURSE NOTICED BLOOD IN THE LUER LINES. BOTH START-UP KIT (SUK) AND CATHETER WILL BE RETURNED. NO FURTHER INFORMATION PROVIDED ON PATIENT CONDITION OR IF TREATMENT WAS CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5677251 ↗
• MalfunctionMay 6, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PATIENT USE WITH THE COOL LINE CATHETER A POSSIBLE LEAK WAS OBSERVED. A MALE PATIENT WAS HOSPITALIZED AND REQUIRED THERAPEUTIC TREATMENT FOR FEVER MANAGEMENT. A COOL LINE CATHETER WAS PLACED IN THE RIGHT SUBCLAVIAN. THE INSERTION WAS SMOOTH AND WAS PERFORMED BY AN EXPERIENCED PHYSICIAN IN ONE ATTEMPT. AFTER 6 DAYS OF DWELL TIME THE NURSE NOTICED THE INSERTION SITE OF THE PATIENT TO BE SWOLLEN AND PUFFY (SIGNS OF INFILTRATION). IT WAS NOTED THAT THE SALINE BAG WAS EMPTY. THERE WAS NO EVIDENCE OUTSIDE THE PATIENT OF ANY FLUID. THE CATHETER WAS REMOVED AND THE SWOLLEN SITE WAS TREATED WITH A DRESSING PLACED OVER THE SITE. ANOTHER CATHETER WAS PLACED FOR A CENTRAL LINE. IT WAS LATER REPORTED, AFTER THE EVENT, THE INSERTION SITE SWELLING HAD GONE DOWN AT THE INSERTION SITE. THERE WAS NO PATIENT SEQUELAE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5639021 ↗
• MalfunctionApr 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A (B)(6) PATIENT WAS HOSPITALIZED WITH A HEAD TRAUMA. THE REASON FOR IVTM THERAPY WAS FOR FEVER MANAGEMENT. A COOL LINE CATHETER WAS INSERTED IN RIGHT INTERNAL JUGULAR VEIN. THE DWELL TIME FOR THE CATHETER WAS 5 DAYS. DURING REMOVAL THE PHYSICIAN EXPERIENCED DIFFICULTY AND COULD NOT REMOVE THE CATHETER. ACCORDING TO THE PHYSICIAN IN CHARGE, IT WAS POSSIBLE TO PULL THE COOL LINE OUT UP TO THE LOCATION OF THE PROXIMAL BALLOON, BUT RESISTANCE WAS FELT AFTER THAT POINT. ECHO FINDINGS SHOWED SOMETHING WHITE AT THE DISTAL BALLOON. IT APPEARED THAT SOME SOFT TISSUE OR THE LIKE WAS SNAGGED. A SURGICAL PROCEDURE WAS REQUESTED OF A CARDIOVASCULAR SURGEON. AN INCISION WAS MADE AT THE LOCATION OF THE CATHETER INSERTION, AND THE CATHETER WAS REMOVED BY PULLING SOFT TISSUE APART USING KELLY CLAMPS. THE PRESENCE OF TISSUE ON THE REMOVED CATHETER WAS NOT CONFIRMED. THE PHYSICIAN IN CHARGE DID NOT THINK THAT THIS CASE INVOLVES A MALFUNCTION OF THE DEVICE, SUCH AS A CATHETER BREAKAGE. THE PHYSICIAN SPECULATED THE REASON WHY THE CATHETER COULD NOT BE REMOVED SMOOTHLY, AND SAID THAT SOFT TISSUE MIGHT HAVE BEEN STUCK DUE TO A STRUCTURAL ISSUE OF THE DEVICE, SUCH AS THE UNEVENNESS A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5601133 ↗
• MalfunctionApr 8, 2016Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER 3 DAYS OF IVTM TREATMENT A LEAK WAS OBSERVED. THE PATIENT WAS HOSPITALIZED FOR A SAH (SUBARACHNOID HEMORRHAGE). THE PATIENT WAS TREATED WITH THE IVTM THERMOGARD FOR POST-SURGERY FEVER MANAGEMENT. IT WAS REPORTED THAT THE PATIENT'S BODY TEMPERATURE WAS WELL CONTROLLED. ON THE THIRD DAY AFTER THE TREATMENT BEGAN, IT WAS OBSERVED THAT THE SALINE LEVEL WAS LOW. IT WAS DETERMINED THAT APPROXIMATELY 50-100 ML OF SALINE LEAKED INTO THE PATIENT. NO ERROR MESSAGE OR ALARM WAS NOTICED. WHEN THE SALINE INFUSION BAG WAS REPLACED, BLOOD WAS OBSERVED IN THE COOL LINE CATHETER AND SUK (STAR-UP-KIT). THE USE OF THERMOGARD WAS TERMINATED AND THE CATHETER WAS REMOVED. THE CATHETER WAS INSPECTED BY THE USER AND THEY STATED THAT NO SIGN OF A LEAK WAS OBSERVED. FEVER MANAGEMENT WAS MAINTAINED BY THE ADMINISTRATION OF ANTIPYRETICS (NSAIDS). THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5565136 ↗
• MalfunctionMar 28, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A (B)(6) MALE PATIENT, WEIGING (B)(6) WAS HOSPITALIZED FOR POST CARDIAC ARREST. THE REASON FOR THERAPEUTIC IVTM WAS FOR HYPOTHERMIA. THE PATIENT TEMPERATURE AT THE START OF THERAPY WAS 36.3° CELSIUS. THE THERMOGARD CONSOLE WAS SET TO MAX MODE AND THE TEMPERATURE WAS SET AT 33° CELSIUS. AN ESOPHAGEAL AND RECTAL TEMPERATURE PROBES WERE USED TO MEASURE PATIENT TEMPERATURE. A ZOLL COOL LINE CATHETER WAS SUCCESSFULLY PLACED INTO THE RIGHT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. THE INSERTION WAS REPORTEDLY SMOOTH. AFTER 2 HOURS, THE AIRTRAP ALARMED ON THE CONSOLE. THE HOSPITAL STAFF OBSERVED BLOOD BACKING UP INTO THE ZOLL START-UP KIT (SUK) LINE. NO LEAKS OR BREAKS WERE OBSERVED IN THE SUK TUBING. AFTER THE LEAK WAS DISCOVERED, THE CATHETER WAS DISCONNECTED AND IT APPEARED THERE WAS ONLY APPROXIMATELY 100-150ML OF SALINE LEFT IN THE BAG. ANOTHER ZOLL COOL LINE CATHETER WAS IMMEDIATELY PLACED AND THE PATIENT WAS ABLE TO SUCCESSFULLY CONTINUE WITH THE THERAPY. NO ADVERSE PATIENT SEQUELAE REPORTED TO THE PATIENT. LATER THE STAFF HOOKED UP A 10 CC SALINE SYRINGE TO THE CATHETER AND A FINE STREAM OF SALINE WAS OBSERVED COMING FROM THE PROXIMAL END OF THE DISTAL BALLOON ON THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5530756 ↗