QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) IC-4593Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00849111075282), received between Apr 28, 2017 and Aug 23, 2026 — classified as 13 deaths, 20 injuries, 132 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (87 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 165 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50397471 ↗
• MalfunctionApr 3, 2026Difficult to Remove

  THE CUSTOMER CONTACTED ZOLL AFTER COMPLETING IVTM THERAPY ON A PATIENT AND WAS ATTEMPTING TO REMOVE THE QUATTRO CATHETER (LOT # UNKNOWN). BEFORE REMOVAL, THEY EXTRACTED RESIDUAL SALINE FROM THE CATHETER BALLOONS BUT DID NOT USE THE SYRINGE PROVIDED WITH THE CATHETER KIT. THE CUSTOMER REPORTED THEY WERE UNABLE TO REMOVE THE CATHETER DUE TO RESISTANCE, ALTHOUGH ALL SALINE HAD BEEN REMOVED FROM THE CATHETER. SINCE THE CUSTOMER CONFIRMED THEY HAD ALREADY FOLLOWED ZOLL'S INSTRUCTIONS FOR USE (IFU) AND WERE STILL EXPERIENCING RESISTANCE, ZOLL TECH SUPPORT ADVISED THEM TO DO AN X-RAY TO IDENTIFY THE SOURCE OF THE RESISTANCE AND CALL BACK. 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 24779755 ↗
• MalfunctionApr 20, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER EXPERIENCED DIFFICULTY PRIMING A NEW SALINE BAG, SUSPECTING IMPROPER SPIKING OF THE PREVIOUS BAG THAT RESULTED IN VOLUME LOSS. AFTER RECONNECTING THE START-UP KIT (SUK) TUBING PROPERLY AND RESTARTING THE THERMOGARD CONSOLE, THERAPY RESUMED. HOWEVER, LATER IN THE DAY, THE CUSTOMER REPORTED A SUSPECTED FLUID LOSS IN THE 1-LITER SALINE BAG. THE VOLUME OF SALINE TO HAVE ENTERED THE PATIENT'S BLOODSTREAM IS UNKNOWN. PER THE REPORTER, THE QUATTRO CATHETER (LOT# UNKNOWN) WAS PLACED IN THE RIGHT FEMORAL VEIN WITH AN ARTERIAL LINE AT THE SAME SITE. THE CUSTOMER WAS ADVISED THAT IT APPEARED TO BE A LEAK IN THE CATHETER AND REQUESTED TO REPLACE THE CATHETER. THE PATIENT REACHED THE TARGET TEMPERATURE AND WAS IN THE MAINTENANCE PHASE. THE CATHETER WAS SUCCESSFULLY REPLACED, PATIENT THERAPY WAS COMPLETED, AND THE PATIENT WAS RE-WARMED WITHOUT ANY FURTHER INCIDENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870226 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED A POSSIBLE QUATTRO CATHETER (LOT # UNKNOWN) LEAK DURING THE IVTM THERAPY REWARMING PHASE. NO FURTHER DETAILS WERE PROVIDED REGARDING CATHETER PLACEMENT, AS THE PATIENT HAD BEEN TRANSFERRED FROM ANOTHER FACILITY WITH THE CATHETER ALREADY INSERTED INTO THE RIGHT FEMORAL VEIN. THE CUSTOMER USED THREE SALINE BAGS WITHOUT ANY LEAKS AROUND THE PATIENT OR ERROR MESSAGES. THE CUSTOMER REPLACED THE SALINE (NS) BAG EVERY THREE HOURS WITHOUT PERFORMING A CATHETER LEAK CHECK. PER THE CUSTOMER, IT WAS A VERY SLOW LOSS OF FLUID. FOLLOWING THE CALL, THE CUSTOMER PERFORMED A CATHETER TEST AND FOUND BLOOD IN THE SYRINGE, SUGGESTING THE CATHETER LEAK AND THE INFUSION OF APPROXIMATELY 1000 ML OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE TREATMENT WAS DISCONTINUED AFTER THE CATHETER WAS REMOVED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733994 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN UNDER FLUOROSCOPY IN THE CATH LAB FOR IVTM THERAPY. DURING THE MAINTENANCE PHASE OF THE TREATMENT WITHIN 48 HOURS OF KEEPING THE PATIENT NORMOTHERMIC AT 36 °C, THE THERMOGARD HQ CONSOLE GENERATED AN AIR TRAP ALARM. THE CUSTOMER NOTICED THAT THE 500-ML SALINE BAG WAS DRY. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK, AND THERE WAS NO LEAKAGE SEEN FROM WITHIN THE INSERTION SITE, AND NOTHING WAS SEEN EXTERNALLY. WHEN THE CUSTOMER PROCEEDED TO CHANGE TO THE SECOND SALINE BAG, THEY ALSO REPLACED THE THERMOGARD HQ CONSOLE. TWO HOURS AFTER RESUMING THE TREATMENT, THE SECOND SALINE BAG DEPLETED FROM 500 ML TO 50 ML. THE CUSTOMER NOTICED THE SALINE BAG DEPLETION BEFORE THE SECOND THERMOGARD HQ CONSOLE DISPLAYED ANY ALARM. THE CUSTOMER REMOVED THE CATHETER AND DISCONTINUED THE IVTM THERAPY. THE CUSTOMER SUSPECTED 850 MILLILITERS OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 20884009 ↗
• DeathNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE QUATTRO CATHETER (LOT# UNKNOWN) WAS USED TO PROVIDE IVTM TREATMENT FOR A PATIENT DUE TO OUT-OF-HOSPITAL CARDIAC ARREST. THE CATHETER WAS PLACED IN THE FEMORAL VEIN BY A RESIDENT SUPERVISED BY AN ATTENDING PHYSICIAN IN THE EMERGENCY DEPARTMENT. PER THE REPORTER, THE GUIDEWIRE WAS PLACED UNTIL THE 23 CM MARK, AND THE QUATTRO CATHETER WAS PLACED AT THE 42 CM MARK. THE INSERTION PROCEDURE WAS SMOOTH. THE CATHETER WAS SECURED TO THE SKIN NEAR THE PLACEMENT SITE. THE CATHETER DWELL TIME WAS LESS THAN 12 HOURS. THE PATIENT WAS TRANSPORTED TO A CT SCAN SHORTLY AFTER CATHETER PLACEMENT TO CONFIRM ITS CORRECT POSITIONING, REVEALING THE PERICARDIAL EFFUSION AND THE QUATTRO CATHETER TIP POSITIONED WITHIN THE RIGHT ATRIUM. CARDIOTHORACIC (CT) SURGERY WAS CONSULTED FOLLOWING THE PATIENT'S CARDIAC ARREST IN THE EMERGENCY DEPARTMENT, WHICH RESULTED IN THE PATIENT'S DEATH.

  Patient problems: Pericardial Effusion

  MAUDE report 20767152 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER CONTACTED THE ZOLL TECH LINE FOR HELP WITH AN "AIR TRAP" ALARM DURING THE FEVER PREVENTION MODE OF THERAPY POST HYPOTHERMIA PROTOCOL. THE IVTM THERAPY, WHICH WAS ADMINISTERED THROUGH A RIGHT FEMORAL QUATTRO CATHETER (LOT #UNKNOWN), HAD BEEN ONGOING FOR THREE DAYS. THE CUSTOMER NOTED THAT THE 500-ML SALINE BAG WAS EMPTY, SO THEY SPIKED ANOTHER SALINE BAG BUT NEEDED ASSISTANCE REPRIMING THE START-UP KIT (SUK). UPON INSPECTION, THE CUSTOMER DID NOT OBSERVE SALINE AROUND THE PATIENT OR THE THERMOGARD HQ CONSOLE. THE ZOLL TECH LINE SUCCESSFULLY PERFORMED BOTH CATHETER INTEGRITY TESTS ACCORDING TO THE IFU, SUSPECTING A CATHETER LEAK. THE CUSTOMER WAS ADVISED TO REMOVE OR REPLACE THE CATHETER BASED ON THE PHYSICIAN'S DISCRETION. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626591 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY USING A QUATTRO CATHETER (LOT # 199451), THE CUSTOMER OBSERVED AN EMPTY SALINE BAG AND THE PRESENCE OF BLOOD IN THE START-UP KIT (SUK) (LOT # 194965) TUBING, SUGGESTING A CATHETER LEAK. IN ADDITION, WHEN THE ROLLER PUMP WAS RUNNING, THE CUSTOMER NOTICED A BIT OF AIR AND A SMALL AMOUNT OF BLOOD MIXED TOGETHER, AND THERE WAS ALSO A SALINE LEAK AROUND THE SUK TUBING NEAR THE ROLLER PUMP. THE CUSTOMER PERFORMED THE CATHETER LEAK CHECK PER IFU. PER THE REPORTER, THE CATHETER AND THE SUK WERE NOT REPLACED AS THE ISSUE OCCURRED ON THE 4TH DAY OF THE TREATMENT. THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582234 ↗
• MalfunctionSep 19, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A QUATTRO CATHETER (LOT #192678) WAS UTILIZED TO PROVIDE IVTM THERAPY FOR A POST-CARDIAC ARREST PATIENT. ALTHOUGH THE CUSTOMER DID NOT SPECIFY THE INSERTION SITE, THE CATHETER INSERTION WAS SMOOTH. THE CUSTOMER REPORTED THAT DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, SALINE WAS DRAINING OUT OF THE 500-ML SALINE BAG, WHICH IS SUPPOSED TO BE A CLOSED SYSTEM. THE THERMOGARD SYSTEM HAD NOT TRIGGERED ANY ALARMS. ZOLL IVTM TERRITORY MANAGER ASSISTED THE CUSTOMER IN TROUBLESHOOTING WHERE SALINE COULD BE GOING AND IF THERE WAS A BREACH IN THE BALLOONS. THE DECISION WAS MADE TO STOP THERAPY, REMOVE THE CATHETER, AND SWITCH TO ARTIC SUN FOR COOLING. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257880 ↗
• MalfunctionAug 10, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT # UNKNOWN) WAS UTILIZED TO PROVIDE IVTM THERAPY TO A PATIENT. THE CATHETER HAD BEEN INSERTED INTO THE RIGHT FEMORAL VEIN. ABOUT 16 HOURS AFTER THE INITIATION OF THE TREATMENT, THE 500-ML SALINE BAG WAS NOTED AS EMPTY. NO SALINE FLUID WAS OBSERVED NEAR THE CONSOLE OR THE PATIENT, AND NO THERMOGARD CONSOLE ALARM WAS ACTIVATED. ZOLL TECH SUPPORT SUSPECTED A CATHETER LEAK, ADVISING THE CUSTOMER TO CONSIDER CATHETER REMOVAL AT THE PHYSICIAN'S DISCRETION. THE PHYSICIAN EXPRESSED INTEREST IN DISCONTINUING THERAPY AND TRANSITIONING TO PASSIVE REWARMING; HOWEVER, DUE TO SHIFT CHANGE, THE CATHETER REMAINED IN PLACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956917 ↗
• MalfunctionJun 28, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A POST-CARDIAC ARREST PATIENT UNDERWENT NORMOTHERMIA PROTOCOL IVTM THERAPY. A QUATTRO CATHETER (LOT# UNKNOWN) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. AFTER APPROXIMATELY 10 HOURS, THE NURSE NOTICED A DEPLETION OF THE 500-ML SALINE BAG. NO ALARMS WERE REPORTED FROM THE THERMOGARD CONSOLE AND THE CONSOLE WAS VERIFIED TO BE FUNCTIONAL. PER THE REPORTER, THE NURSE DID NOT KNOW ABOUT THE CATHETER LEAK TEST. AFTER REPLACING THE 500-ML SALINE BAG, THE CUSTOMER NOTICED THAT THE SECOND BAG HAD DEPLETED ANOTHER 30-ML. GIVEN THE ABSENCE OF SALINE IN OR AROUND THE PATIENT'S BED OR CONSOLE, THE CUSTOMER SUSPECTED A CATHETER LEAK AND THE INFUSION OF 530 ML OF SALINE INTO THE PATIENT'S BLOODSTREAM. ACCORDING TO THE REPORTER, THE PHYSICIAN DISCONTINUED IVTM THERAPY AND USED A CATHETER AS A CENTRAL LINE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639752 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED USING A QUATTRO CATHETER (LOT #UNKNOWN). DURING THE THERAPY, THE NURSE NOTICED AN EMPTYING SALINE BAG AND REALIZED THAT 250 ML SALINE BAG WAS USED INSTEAD OF 500 ML SALINE BAG. THE 250 ML SALINE BAG WAS EMPTYING BECAUSE UPON PRIMING, AROUND 200-250 ML OF SALINE WILL BE CIRCULATING IN THE START-UP KIT (SUK) TUBING. THE NURSE REPLACED THE BAG WITH 500 ML SALINE BAG TO CONTINUE THE THERAPY. DURING THE COOLING PHASE, THE NURSE NOTED DECREASING VOLUME OF SALINE FROM THE 500 ML SALINE BAG. NO LEAKED SALINE WAS NOTED AROUND THE THERMOGARD XP IVTM SYSTEM OR ON THE PATIENT'S BED. THE NURSE SUSPECTED A CATHETER LEAK AND CALLED THE ZOLL TECH LINE FOR TROUBLESHOOTING. PER ZOLL TECH LINE PERSONNEL'S INSTRUCTION, THE NURSE PERFORMED THE LEAK CHECK ON THE CATHETER AND NOTED BLOOD BACKING UP WHILE PERFORMING THE TEST. ZOLL TECH LINE PERSONNEL ADVISED THE CUSTOMER TO REPLACE THE CATHETER. THE DWELL TIME OF THE CATHETER WAS 23 HOURS. THE CUSTOMER LEFT THE CATHETER TO USE AS A CENTRAL LINE AND END THERAPY. THE CUSTOMER REPORTED NO INJURY TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478647 ↗
• MalfunctionMay 15, 2024Difficult to Remove; Difficult to Remove

  THE CUSTOMER CALLED THE ZOLL IVTM TECH SUPPORT CUSTOMER SERVICE LINE AND ASKED HOW TO PROPERLY REMOVE THE QUATTRO CATHETER (LOT # UNKNOWN), AS THEY WERE EXPERIENCING RESISTANCE DURING REMOVAL. THE CUSTOMER WAS INSTRUCTED TO DEFLATE THE CATHETER BALLOONS BY REMOVING ALL THE SALINE FROM THE CATHETER USING THE SLIP-TIP SYRINGE AND ATTACHING IT TO THE IN LUER WHILE HAVING THE OUT LUER CLAMPED BEFORE APPLYING THE VACUUM FROM THE SYRINGE. AFTER ENSURING THAT THE NURSE WAS ONLY PULLING SALINE AND LEAVING THE OTHER LUERS OPEN TO THE AIR, THE CUSTOMER EXPERIENCED RESISTANCE WHILE TRYING TO REMOVE THE CATHETER. THE CUSTOMER ATTEMPTED TURNING THE CATHETER WHILE PULLING BACK YET STILL EXPERIENCED RESISTANCE. THERE WAS NO OCCLUSION (E.G., IVC FILTER, IMPLANT, OR ANOTHER DEVICE PLANTED IN THE SAME VEIN) OR INCREASED TORTUOSITY IN THE PATIENT'S VEIN. ZOLL CLINICAL TERRITORY ASSOCIATE RECOMMENDED THE CUSTOMER REMOVE THE CATHETER UNDER FLUOROSCOPY IF RESISTANCE IS MET AND IF UNABLE TO REMOVE THE CATHETER MANUALLY. THE VASCULAR SURGERY TEAM CONSULTED THE ISSUE, BUT NO SURGICAL INTERVENTION WAS NEEDED. THE CUSTOMER PUT A GUIDEWIRE BACK THROUGH THE CATHETER TO STRAIGHTEN IT OUT. THE CATHETER WAS REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327175 ↗
• MalfunctionMay 10, 2024Difficult to Advance; Difficult to Advance

  THE CUSTOMER REPORTED DIFFICULTY IN ADVANCING THE QUATTRO CATHETER (LOT 195901) OVER THE GUIDEWIRE (LOT 195901) DURING PLACEMENT BY AN EMERGENCY DEPARTMENT (ED) RESIDENT. THE PATIENT HAD NORMAL ANATOMY. THE CUSTOMER DID NOT REPORT ANY RESISTANCE WITH GUIDEWIRE INSERTION. THE CUSTOMER REPORTED THE RESIDENT WAS PUSHING WAY HARDER THAN SHE SHOULD HAVE TO GET CATHETER INTO THE VESSEL. THE GUIDEWIRE WAS CONFIRMED TO BE IN THE CORRECT POSITION IN THE VESSEL AND CATHETER INSERTION WAS INITIALLY VERY SMOOTH UNTIL THE CATHETER WAS ABOUT ¾ OF THE WAY INSERTED, THEN RESISTANCE WAS FELT. THE RESIDENT TRIED TO REMOVE THE GUIDEWIRE, BUT IT WAS SNAGGED ON SOMETHING, AND RESISTANCE WAS FELT DURING THE ATTEMPT TO REMOVE THE GUIDEWIRE. INSTEAD OF REMOVING THE ENTIRE CATHETER AND GUIDEWIRE TOGETHER, SHE PULLED HARDER ON THE GUIDEWIRE, AND IT UNRAVELED. SHE THEN REMOVED BOTH THE ENTIRE CATHETER AND GUIDEWIRE SIMULTANEOUSLY WITHOUT ISSUE, AND IT WAS ALL INTACT. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO KINKS WERE OBSERVED ON THE GUIDEWIRE PRIOR TO OR AFTER THE REMOVAL. A NEW CATHETER WAS PLACED WITHOUT ISSUE. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294458 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ZOLL RECEIVED MEDWATCH REPORT #MW5153022 ON 05 APRIL 2024 FOR THE EVENT REPORTED BELOW: A PATIENT WITH KNOWN, PRE-EXISTING VASCULAR PROBLEMS WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY AFTER OUT-OF-HOSPITAL CARDIAC ARREST (OHCA). A QUATTRO CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN, AND MULTIPLE OTHER LINES WERE ALSO PLACED, ALTHOUGH THE SPECIFIC LOCATIONS WERE NOT SPECIFIED. THE CUSTOMER REPORTED POTENTIAL IVC (INFERIOR VENA CAVA) THROMBOSIS VS. VEGETATION ASSOCIATED WITH THE CATHETER, WITH CLOT FORMATION IDENTIFIED VIA ECHOCARDIOGRAM (ECHO). IT IS UNKNOWN WHETHER A BLOOD COAGULOPATHY WAS DONE PRIOR TO THE HOSPITALIZATION. THE PATIENT WAS IN A HIGH-RISK CATEGORY FOR DEEP VEIN THROMBOSIS (DVT) AND HAD A RECENT THROMBOEMBOLIC CEREBROVASCULAR ACCIDENT (CVA), SUGGESTING AN UNDERLYING HYPERCOAGULOPATHY. THE PATIENT WAS NON-AMBULATORY BEFORE HOSPITALIZATION, AND IT IS UNCLEAR IF DVT PROPHYLAXIS WAS GIVEN BEFORE THROMBOSIS DETECTION. THE PATIENT WAS SYSTEMATICALLY ANTICOAGULATED WITH HEPARIN AND LATER ELIQUIS, AND NO VESSEL INJURY OCCURRED DUE TO THE QUATTRO CATHETER. NO OTHER INTERVENTION WAS REQUIRED TO MITIGATE THE THROMBOSIS. THE CA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19218171 ↗
• MalfunctionApr 20, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  TWO EXPIRED QUATTRO CATHETERS (LOT# 185592) WERE USED FOR EDUCATIONAL PURPOSES. UPON SET-UP AND PRIMING, AS SOON AS THE FIRST BALLOON STARTED TO FILL, IT STARTED LEAKING. BOTH CATHETERS LEAKED OUT OF MULTIPLE OPENINGS. THE TWO CATHETERS HAD JUST BEEN OPENED AND HAD NEVER BEEN USED FOR EDUCATIONAL PURPOSES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149757 ↗
• MalfunctionApr 20, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  TWO EXPIRED QUATTRO CATHETERS (LOT# 185592) WERE USED FOR EDUCATIONAL PURPOSES. UPON SET-UP AND PRIMING, AS SOON AS THE FIRST BALLOON STARTED TO FILL, IT STARTED LEAKING. BOTH CATHETERS LEAKED OUT OF MULTIPLE OPENINGS. THE TWO CATHETERS HAD JUST BEEN OPENED AND HAD NEVER BEEN USED FOR EDUCATIONAL PURPOSES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149756 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE IVTM THERAPY USING A QUATTRO CATHETER (LOT #UNKNOWN), THE CUSTOMER NOTICED SALINE VOLUME DEPLETION OF APPROXIMATELY 125 ML WHILE IN THE MAINTENANCE PHASE OF THERAPY. THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) ) DID NOT GENERATE AN ALARM, AND THE PATIENT WAS AT THE GOAL TEMPERATURE OF 33°C. THE DWELL TIME OF THE CATHETER WAS APPROXIMATELY 6 HOURS. NO LEAKED SALINE WAS NOTED ON THE PATIENT'S BED OR AROUND THE THERMOGARD SYSTEM, AND NO BLOOD TINGE WAS NOTED IN THE TUBING. THE CATHETER LEAK WAS PERFORMED PER IFU, AND NO LEAKS WERE NOTED. SALINE OUT FLOWED FROM THE CATHETER WHEN INJECTED AS EXPECTED, AND NEGATIVE PRESSURE WAS MAINTAINED. ZOLL TECH SUPPORT ASKED THE CUSTOMER TO PAUSE THE THERAPY AND REPLACE THE CATHETER; HOWEVER, THE PHYSICIAN DECIDED TO END INTRAVASCULAR THERAPY AND USE EXTERNAL TEMPERATURE CONTROLS. NO DEVICE MALFUNCTION WAS REPORTED ON THE THERMOGARD SYSTEM, AND IT WAS PLACED BACK ON THE FLOOR FOR TREATING OTHER PATIENTS. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067864 ↗
• DeathMar 19, 2024Use of Device Problem; Use of Device Problem

  A QUATTRO CATHETER (LOT #UNKNOWN) WAS PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO INITIATE AN IVTM THERAPY FOR A 54-YEAR-OLD FEMALE HYPOTHERMIC PATIENT. THE CATHETER INSERTION WAS SMOOTH AND PLACED WITHOUT DIFFICULTY IN ONE ATTEMPT. THE NURSE MENTIONED THAT THE PATIENT WAS SMALL IN STATURE (40 KG, 157 CM). PER THE REPORTER, THIS WAS THE PHYSICIAN'S FIRST CATHETER PLACEMENT EXPERIENCE. AFTER PLACING THE CATHETER, AN X-RAY WAS PERFORMED. THE RADIOLOGIST CALLED THE NURSE AND REPORTED THAT THE CATHETER WAS IN THE PATIENT'S HEART AND RECOMMENDED WITHDRAWING THE CATHETER TO ABOUT 20 CM MARK. THE QUATTRO CATHETER WAS AT THE HUB, AND THERE WAS NO WAY TO MOVE THE CATHETER BACK TO THE 20 CM MARK PER RECOMMENDATION. THE NURSE CALLED THE ZOLL CLINICAL EDUCATOR FOR TROUBLESHOOTING. SINCE THERE IS NO WAY TO MOVE THE CATHETER BACK TO 20 CM, THE ZOLL CLINICAL EDUCATOR RECOMMENDED THE PHYSICIAN PULL BACK THE CATHETER TO THE 38 CM MARK AND RE-X-RAY IF THAT WOULD MAKE A DIFFERENCE. HOWEVER, THE PHYSICIAN HAS DECIDED NOT TO CONTINUE WITH THE QUATTRO CATHETER AND TO REMOVE IT. THE CUSTOMER'S SITE ALSO HAD A SOLEX 7 CATHETER, WHICH COULD NOT BE PLACED IN THE UPPER BODY DUE TO DVT. THE RIGHT INTRAJUG

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18938014 ↗
• DeathFeb 16, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE EMERGENCY DEPARTMENT (ED) INSERTED A QUATTRO CATHETER (LOT UNKNOWN) FOR THE FIRST TIME AND THE BALLOON HAD A LEAK. THE QUATTRO CATHETER IS NEW TO THEIR HOSPITAL, THIS WAS THE FIRST TIME IT WAS INSERTED INTO ONE OF THEIR PATIENTS BY A PROVIDER. THEY PREVIOUSLY USED ICY AND COOL LINE. THE LEAK OCCURRED IN THE ED AND WAS DISCOVERED QUICKLY. THE ED PHYSICIAN PUT IN ANOTHER CATHETER ON THE OPPOSITE GROIN. THE SITE BELIEVES THEY USED AN ICY CATHETER THE SECOND TIME. THE SAME CONSOLE WAS USED TO CONTINUE THERAPY. UPON FOLLOW UP, THE CUSTOMER REPORTED UNFORTUNATELY, THE FEMALE PATIENT PASSED DUE TO A CARDIAC ARREST. THE PATIENT WAS BRAIN DEAD. TTM THERAPY HAD STOPPED. THE SITE BELIEVES IT WAS ENDED DAYS PRIOR. THE STAFF DID NOT SAVE THE CATHETER UPON REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED. PER THE CUSTOMER, HER DEATH WAS NOT RELATED TO THE ZOLL CATHETER.

  Patient problems: Cardiac Arrest

  MAUDE report 18726976 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A QUATTRO CATHETER (LOT #UNKNOWN) WAS PLACED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INITIATE THE IVTM THERAPY. DURING THE REWARMING PHASE, THE CUSTOMER NOTICED AN EMPTY SALINE BAG. THE CUSTOMER REPLACED THE SALINE BAG, BUT IT GOT EMPTIED AGAIN. NO LEAKED FLUID WAS OBSERVED ON THE PATIENT'S BED, FLOOR, OR IN AND AROUND THE THERMOGARD XP IVTM SYSTEM. IT IS UNKNOWN WHETHER THE THERMOGARD XP IVTM SYSTEM GENERATED AN ALARM. A CATHETER BALLOON LEAK AND INFUSION OF APPROXIMATELY 150-200ML OF 0.9% NS INTO THE PATIENT'S BLOODSTREAM ARE SUSPECTED. THE DWELL TIME OF THE CATHETER AT THE TIME OF THE ISSUE WAS APPROXIMATELY 30 HOURS. PER THE PULMONOLOGIST'S ORDER, THE CATHETER WAS DISCONNECTED FROM THE THERMOGARD SYSTEM, AND THE PATIENT WAS MONITORED FOR REWARMING INDEPENDENTLY OF THE THERMOGARD SYSTEM. THE CATHETER WAS REMOVED WHEN THE PATIENT REACHED A TARGET TEMPERATURE OF 37°C. THE CUSTOMER DID NOT REPORT ANY DEVICE MALFUNCTION ON THE THERMOGARD SYSTEM. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641370 ↗
• MalfunctionAug 25, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE CUSTOMER NOTICED A VERY SMALL AMOUNT OF BLOOD-TINGE IN THE START-UP KIT (SUK) TUBING. A BALLOON LEAK WAS SUSPECTED ON THE QUATTRO CATHETER (LOT #UNKNOWN). THE CATHETER WAS REPLACED AND TREATMENT WAS COMPLETED WITHOUT ANY ISSUES. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17621160 ↗
• MalfunctionAug 13, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE REWARMING PHASE OF IVTM THERAPY, CUSTOMER REPORTED THAT A 1000ML SALINE BAG WAS REPLACED BECAUSE IT EMPTIED, AND A 500ML SALINE BAG HAD STARTED TO EMPTY. WHEN THE CUSTOMER NOTICED THE 1000ML BAG EMPTIED, AND NO SALINE WAS FOUND ON THE THERMOGARD IVTM SYSTEM, PATIENT'S BED OR ON THE FLOOR. THE CUSTOMER REPLACED THE 1000ML SALINE BAG WITH A 500ML SALINE BAG, AND THE THERMOGARD IVTM SYSTEM AND THE START-UP KIT (SUK) TO CONTINUE WITH REWARMING TREATMENT. LATER, THE CUSTOMER NOTICED THE 500ML BAG STARTED TO EMPTY AND CHECK FOR FLUID LEAK. NO SALINE WAS FOUND ON THE THERMOGARD IVTM SYSTEM, PATIENT'S BED OR ON THE FLOOR, AND NO BLOOD-TINGE WAS OBSERVED IN THE CATHETER, ASSUMED TO BE INFUSED INTO PATIENT. THE CUSTOMER CALLED A ZOLL EDUCATOR, AND CUSTOMER WAS ADVISED THAT THERE'S APPEARED TO BE A LEAK IN THE BALLOON OF THE ICY CATHETER (LOT #188022) AND STOP TREATMENT. THE CUSTOMER PLACED A NEW CATHETER TO CONTINUE WITH TREATMENT. PER REPORTER, THE FIRST THERMOGARD IVTM SYSTEM WAS FUNCTIONING PROPERLY WITH NO ALARMS OR ERROR MESSAGES, IT WAS CHANGED AS AN EFFORT TO ENSURE THERE WERE NO UNIDENTIFIED CONSOLE ISSUES. BASED ON NURSE RECOLLECTION, APPROX. 1200ML INFUSED IN THE PATIENT

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17537853 ↗
• MalfunctionAug 4, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY ON A 170KG MALE PATIENT, THE CUSTOMER REPORTED THAT THREE 500ML SALINE BAGS WERE REPLACED. THE FIRST 500ML SALINE BAG WAS NOTICED LOW WHEN THE CUSTOMER HAD DISCONNECTED THE PATIENT TO GO TO COMPUTERIZED TOMOGRAPHY (CT) SCAN AND USED TUBE CLAMPS TO THE TUBING, SOME SALINE FLUID WAS LOST IN THE PROCESS. THE PATIENT RETURNED FROM CT SCAN AND WAS RECONNECTED, THE CUSTOMER TRIED REPRIMING WITH 250 ML LEFT IN THE SALINE BAG, AND THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP" WARNING ALARM. THE CUSTOMER CALLED ZOLL TECH LINE DUE TO THE LOW SALINE AND "AIR TRAP" WARNING ALARM. ZOLL PERSONNEL INSTRUCTED THE CUSTOMER TO PLACE A NEW 500ML SALINE BAG BECAUSE THE LOW SALINE BAG WAS NOT SPIKED, AND THE TUBING HAD AIR IN IT. THE CUSTOMER PLACED A NEW BAG, AND REWARMING TREATMENT STARTED WITH THE SAME THERMOGARD IVTM SYSTEM. THE COOLING PHASE OF TREATMENT HAD NO ISSUE, PATIENT WAS COOLED TO 36 DEGREES FROM 39 DEGREES. THE CUSTOMER DID NOT PERFORM LEAK CHECK PER IFU WHEN THE FIRST SALINE BAG HAD LOST FLUID. DURING OVER A PERIOD OF ABOUT 12 HOURS INTO TREATMENT, THE SECOND AND THIRD 500ML SALINE BAGS HAD EMPTIED, BUT ONE OF THE TIMES MAY HAVE BEEN BECAUSE THE CUSTOMER PUNCTUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461359 ↗
• MalfunctionJun 15, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT # 188009) WAS USED IN AN IVTM THERAPY. THE CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN TO INITIATE THE TREATMENT. THE COOLING AND REWARMING PHASES OF THE TREATMENT WERE COMPLETED, AND THE PATIENT WAS REWARMED FOR AT LEAST 12 HOURS. THE CATHETER REMAINED IN PLACE TO HELP SUPPORT NORMOTHERMIA. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, THE STAFF NOTICED THAT THE 500-ML SALINE BAG WAS DRY. THE STAFF PLACED THE THERMOGARD SYSTEM IN STANDBY MODE AND PERFORMED A CATHETER LEAK CHECK. PER THE PHYSICIAN, 10-15 ML OF SALINE WAS INJECTED INTO THE IN LUER OF THE CATHETER, AND ONLY A SMALL AMOUNT OF SALINE RETURNED. THE CATHETER LEAK WAS DISCOVERED AROUND 4 OR 5 AM, AND THE TREATMENT WAS DISCONTINUED BECAUSE TEMPERATURE MANAGEMENT THERAPY WAS ALREADY COMPLETED. LATER DURING THE DAY SHIFT, THE CATHETER WAS REMOVED FROM THE PATIENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140613 ↗