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

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00849111075138), received between Aug 31, 2015 and Nov 21, 2024 — classified as 1 death, 5 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (47 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER (NURSE CLINICAL LEAD) CONTACTED ZOLL TECH LINE SUPPORT TO REPORT A SUSPECTED CATHETER LEAK. THE CUSTOMER OBSERVED A PINK TINGE IN THE START-UP KIT (SUK) TUBING AND THE QUATTRO CATHETER (LOT # 203625) DURING THE REWARMING PHASE OF HYPOTHERMIA THERAPY, WHICH HAD BEEN ONGOING FOR AROUND 23 HOURS. THE PATIENT'S NURSE REPORTED AN AIR TRAP ALARM ON THE THERMOGARD XP CONSOLE AND NOTED THAT THE 500-ML SALINE BAG WAS DEPLETED. THE HEALTHCARE PROVIDER DECIDED TO REMOVE THE CATHETER AND END THE THERAPY AS THE PATIENT WAS NEARLY BACK TO NORMOTHERMIC TEMPERATURE. THE AIR TRAP ALARM WAS CLEARED, AND THE THERMOGARD CONSOLE WAS PLACED BACK ON THE FLOOR FOR CONTINUED CLINICAL USE. LEAK TEST(S) ON THE CATHETER CONFIRMED POTENTIAL CATHETER DAMAGE. THE TOTAL SUSPECTED INFUSED SALINE VOLUME INTO THE PATIENT'S BLOODSTREAM WAS 500 MILLILITERS. THE CUSTOMER CONFIRMED THERE WAS NO SUSPECTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752727 ↗
• MalfunctionAug 15, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY WAS STARTED FOR A PATIENT AFTER THE QUATTRO CATHETER (LOT 183530) WAS PLACED ON (B)(6) 23. THE CATHETER WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT. DURING THE NORMOTHERMIA STAGE OF THERAPY, PINK BLOOD TINGE WAS NOTED IN TUBING AND SALINE BAG. THE DWELL TIME OF THE CATHETER IS UNKNOWN. THE SITE WAS USING CATHETER FOR CENTRAL LINE. IVTM THERAPY WAS DISCONTINUED, AND THE CATHETER WAS REMOVED. THERAPY WAS PERFORMED FOR 12-16 HOURS BEFORE IT WAS DISCONTINUED. THE CUSTOMER BELIEVES THE LEAK WAS LOCATED AT THE SECOND MOST PROXIMAL BALLOON. NO IMPACT OR CONSEQUENCE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549494 ↗
• MalfunctionDec 30, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A QUATTRO CATHETER (LOT #UNKNOWN) WAS INSERTED INTO THE RIGHT FEMORAL OF A 167 CM, 81.6 KG PATIENT. AFTER APPROXIMATELY 20 MINUTES OF IVTM THERAPY, THE THERMOGARD XP IVTM SYSTEM STARTED ALARMING. THE RN WENT TO CHECK THE ALARM AND FOUND THE NS BAG WAS EMPTY AND THE TUBING OF THE START-UP KIT (SUK) WAS FULL OF BLOOD UP TO THE NS BAG. WHILE CATHETER WAS STILL IN PLACE, THE TUBING WAS DISCONNECTED FROM THE CONSOLE AND USING THE INCLUDED SLIP TIP SYRINGE, BLOOD WAS ABLE TO BE ASPIRATED FROM THE BALLOON LUMEN. THE CATHETER WAS REPLACED, AND THE ALARM ON THE CONSOLE WAS CLEARED. THERAPY WAS CONTINUED USING THE SAME CONSOLE. THE CATHETER WAS FLUSHED AFTER IT WAS REMOVED, AND FLUID WAS VISIBLY NOTED TO BE LEAKING OUT OF A HOLE IN THE SECOND BALLOON. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078264 ↗
• MalfunctionFeb 21, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A QUATTRO CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN FOR IVTM THERAPY. AN ARTERIAL LINE WAS ALSO PLACED IN THE LEFT FEMORAL VEIN. AFTER THE PATIENT REACHED THE TARGET TEMPERATURE, THE ARTERIAL LINE WAS REMOVED. THE RE-WARMING PHASE OF THE TREATMENT BEGAN, AND THE TARGET TEMPERATURE WAS SET TO ACHIEVE NORMOTHERMIA. WHEN THE PATIENT'S BODY TEMPERATURE WAS AT 95.5 °F, THE NURSE TOOK THE PATIENT FOR A NON-CONTRAST CT SCAN. THE NURSE STATED THAT THERE WAS NO ISSUE WITH THE TREATMENT UNTIL THEY RETURNED FROM THE CT SCAN. AFTER THE NURSE BROUGHT THE PATIENT BACK AND RE-CONNECTED THE START-UP KIT (SUK) TO THE CATHETER, SHE NOTED THAT THE 500-ML SALINE BAG HAD BEGUN TO RUN DRY. THE PATIENT'S BODY TEMPERATURE WAS AT 94.2 °F AT THIS TIME. THE NURSE CONTACTED ZOLL, AND A CATHETER LEAK CHECK WAS PERFORMED PER THE ZOLL'S NEW IFU. THE NURSE DID NOT REPORT ANY "AIR TRAP" ALARMS DISPLAYED BY THE THERMOGARD CONSOLE. THE ZOLL CLINICAL FIELD SPECIALIST (CFS) ALSO STATED THAT THERE WAS NO ALARM HEARD IN THE BACKGROUND DURING THE PHONE CONVERSATION WITH THE NURSE. THE CFS INSTRUCTED THE NURSE TO PUT THE THERMOGARD CONSOLE IN STANDBY MODE AND DISCONNECT THE SUK. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573568 ↗
• MalfunctionSep 29, 2021Fluid/Blood Leak; Difficult to Advance; Material Integrity Problem; Fluid/Blood Leak; Difficult to Advance; Material Integrity Problem

  A PATIENT WAS HOSPITALIZED TO RECEIVE IVTM THERAPY AFTER CARDIAC ARREST, AND A QUATTRO CATHETER (LOT # 166228) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN FOLLOWING THE STANDARD PROCEDURE PER ZOLL IFU (INSTRUCTIONS FOR USE). A POST-PROCEDURE X-RAY WAS ORDERED AND CONFIRMED THAT THE CATHETER WAS IN THE CORRECT POSITION. THE CUSTOMER REPORTED THAT THE VOLUME OF THE 500-ML SALINE BAG WAS NOTED TO BE DECREASING. THE CUSTOMER DID NOT REPORT AT WHAT STAGE OF THE TREATMENT THE ISSUE WAS NOTED AND WHETHER THE THERMOGARD SYSTEM DISPLAYED AN "AIR TRAP" ALARM. UPON INSPECTION, THERE WERE NO TRACES OF FLUID OBSERVED ON THE CONSOLE, PATIENT'S BED, OR THE FLOOR. THE USER OBSERVED BLOOD IN THE START-UP KIT (SUK) TUBING, AN INDICATION OF A POTENTIAL CATHETER LEAK. THE CATHETER WAS REMOVED, THE SALINE BAG WAS REPLACED, AND A SECOND QUATTRO CATHETER (LOT # 165913) KIT WAS REOPENED. USING THE NEW GUIDEWIRE FROM THE SECOND KIT, THE CUSTOMER ATTEMPTED TO INSERT THE CATHETER INTO THE PATIENT'S LEFT FEMORAL VEIN, FOLLOWING THE STANDARD PROCEDURE PER ZOLL IFU. AS REPORTED, RESISTANCE WAS ENCOUNTERED UPON TRYING TO PLACE THE CATHETER OVER THE GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REMOVED. USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545198 ↗
• MalfunctionSep 29, 2021Fluid/Blood Leak; Difficult to Advance; Material Integrity Problem; Fluid/Blood Leak; Difficult to Advance; Material Integrity Problem

  A PATIENT WAS HOSPITALIZED TO RECEIVE IVTM THERAPY AFTER CARDIAC ARREST, AND A QUATTRO CATHETER (LOT # 166228) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN FOLLOWING THE STANDARD PROCEDURE PER ZOLL IFU (INSTRUCTIONS FOR USE). A POST-PROCEDURE X-RAY WAS ORDERED AND CONFIRMED THAT THE CATHETER WAS IN THE CORRECT POSITION. THE CUSTOMER REPORTED THAT THE VOLUME OF THE 500-ML SALINE BAG WAS NOTED TO BE DECREASING. THE CUSTOMER DID NOT REPORT AT WHAT STAGE OF THE TREATMENT THE ISSUE WAS NOTED AND WHETHER THE THERMOGARD SYSTEM DISPLAYED AN "AIR TRAP" ALARM. UPON INSPECTION, THERE WERE NO TRACES OF FLUID OBSERVED ON THE CONSOLE, PATIENT'S BED, OR THE FLOOR. THE USER OBSERVED BLOOD IN THE START-UP KIT (SUK) TUBING, AN INDICATION OF A POTENTIAL CATHETER LEAK. THE CATHETER WAS REMOVED, THE SALINE BAG WAS REPLACED, AND A SECOND QUATTRO CATHETER (LOT # 165913) KIT WAS REOPENED. USING THE NEW GUIDEWIRE FROM THE SECOND KIT, THE CUSTOMER ATTEMPTED TO INSERT THE CATHETER INTO THE PATIENT'S LEFT FEMORAL VEIN, FOLLOWING THE STANDARD PROCEDURE PER ZOLL IFU. AS REPORTED, RESISTANCE WAS ENCOUNTERED UPON TRYING TO PLACE THE CATHETER OVER THE GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REMOVED. USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545192 ↗
• MalfunctionSep 2, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE QUATTRO CATHETER (LOT # 155467) WAS USED TO PROVIDE IVTM TREATMENT TO A PATIENT AFTER CARDIAC ARREST. THE NURSE REPORTED THAT SHE HAD TO REPLACE THE 500-ML SALINE BAG 3 TIMES ON HER DAY SHIFT. DURING THE MAINTENANCE PHASE OF THE TREATMENT, AIR BUBBLES WERE OBSERVED IN THE TUBING CONNECTED TO THE AIR TRAP CHAMBER. UPON INSPECTION, NO TRACES OF SALINE WERE OBSERVED ON THE FLOOR OR IN THE PUMP RACEWAY OF THE THERMOGARD CONSOLE. ALSO, NO LEAK WAS OBSERVED IN THE TUBING OR FROM THE AIR TRAP CHAMBER. IN ADDITION, IT WAS VERIFIED THAT THE SALINE BAG WAS PROPERLY "SPIKED", AND THE CATHETER/SUK LUER CONNECTIONS WERE INSPECTED WITH NO NOTED ISSUES. THE CUSTOMER SUSPECTED A CATHETER BALLOON LEAK AND INFUSION OF 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE SALINE BAGS WERE REPLACED BEFORE THE THERMOGARD CONSOLE DISPLAYED AN "AIR TRAP" ALARM. THE CATHETER WAS REMOVED. THERE WAS NO DEVICE MALFUNCTION REPORTED ON THE THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419097 ↗
• MalfunctionJun 19, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT WHO SUFFERED A FALL WAS LIFE-FLIGHTED TO A HOSPITAL FOR THE RESULTANT EPIDURAL AND SUBDURAL HEMATOMA. IN THE HOSPITAL, THE PATIENT RECEIVED IVTM THERAPY. A QUATTRO CATHETER (LOT # 144296) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN IN 2 ATTEMPTS WITH NO IMMEDIATE COMPLICATIONS. AT THE TIME OF THE CATHETER PLACEMENT, THE PATIENT HAD A LEFT RADIAL ARTERIAL LINE FOR BLOOD PRESSURE (BP) MONITORING. DURING THE COOLING PHASE OF THE TREATMENT, AFTER ABOUT 45 MINUTES OF OPERATION, THE THERMOGARD CONSOLE DISPLAYED AN ALARM OF TYPE NOT REPORTED BY THE USER. SUBSEQUENTLY, IT WAS NOTED THAT FLUID WITHIN THE OUT LUER TUBING OF THE START-UP KIT (SUK) HAD A REDDISH TINGE (BLOOD), INDICATING A POTENTIAL CATHETER LEAK. FURTHERMORE, IT WAS OBSERVED THAT THE 500-ML BAG OF SALINE SUPPLY WAS NEARLY EMPTY AND CONTAINED SEROSANGUINOUS FLUID. THERE WERE NO TRACES OF SALINE OBSERVED ON THE FLOOR, PATIENT'S BED, OR ON THE CONSOLE. THE QUANTITY OF SALINE POSSIBLY INFUSED INTO THE PATIENT'S BLOODSTREAM WAS UNKNOWN. TREATMENT WAS PAUSED TO REMOVE THE QUATTRO CATHETER, AND A SECOND CATHETER (SOLEX) WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S LEFT JUGULAR VEIN. THE TREATMENT CONTINUED AND WAS CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029638 ↗
• MalfunctionMay 28, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A THERMOGARD XP CONSOLE (S/N (B)(4) AND A QUATTRO CATHETER (LOT # 155467) WERE USED TO PROVIDE IVTM TREATMENT TO A PATIENT WHO NEEDED POST CARDIAC ARREST CARE. THE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED, AND A RADIAL ARTERIAL LINE WAS ALSO PLACED FOR MEDICAL PURPOSES. THE DWELL TIME OF THE CATHETER HAD BEEN APPROXIMATELY 26 HOURS WHEN THE HYPOTHERMIA PHASE ENDED, AND THE REWARMING PHASE STARTED. BEFORE THE INITIATION OF REWARMING, THE PATIENT'S BODY TEMPERATURE WAS MEASURED AT 36 °C. THE TARGET TEMPERATURE WAS SET TO 37°C, AND THE CONSOLE WAS SET TO A CONTROLLED REWARMING RATE OF 0.2°C/HOUR. ABOUT 15 HOURS INTO THE REWARMING PHASE OF THE TREATMENT, IT WAS NOTICED THAT THE PATIENT WAS NOT APPROPRIATELY WARMING, WHICH PROMPTED TROUBLESHOOTING OF THE THERMOGARD SYSTEM. THE PATIENT'S BODY TEMPERATURE WAS AT 36.7 °C WHEN THE ISSUE WAS NOTED. UPON FURTHER VISUAL INSPECTION, THE CUSTOMER NOTED THAT THE TUBING OF THE START-UP-KIT (SUK) (LOT # UNKNOWN) WAS BULGING IN THE AREA AROUND THE ROLLER PUMP, PREVENTING THE PUMP ROTOR FROM TURNING. THE NURSES REPLACED THE 500-ML SALINE BAG TO TROUBLESHOOT THE ISSUE; HOWEVER, THE SUK TUBING WAS STIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905490 ↗
• MalfunctionMar 20, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE QUATTRO CATHETER (LOT # 96599) WAS PLACED IN THE PATIENT'S RIGHT FEMORAL VEIN, AND AN ARTERIAL LINE WAS PLACED IN THE LEFT FEMORAL VEIN. ABOUT 5 HOURS AFTER THE INITIATION OF THE TREATMENT, THE 500-ML SALINE BAG WAS OBSERVED EMPTY. THE USER REPLACED THE SALINE BAG, AND THE TREATMENT RESUMED. HOWEVER, AFTER ABOUT 2 HOURS, THE USER NOTICED THE SECOND SALINE BAG WAS ALSO EMPTY. THERE WAS NO ALARM GENERATED AND NO ERROR CODE DISPLAYED ON THE THERMOGARD CONSOLE. PER USER, THERE WERE NO TRACES OF FLUID ON THE FLOOR, PATIENT'S BED, OR ON THE CONSOLE. CATHETER LEAK AND AN INFUSION OF ABOUT 700 MILLILITERS OF SALINE WERE SUSPECTED. THE THERAPY WAS DISCONTINUED; HOWEVER, THE CATHETER WAS NOT REPLACED. THE QUATTRO LINE WAS LEFT IN PLACE AND USED AS THE CENTRAL LINE. THERE WAS NO DEVICE MALFUNCTION REPORTED ON THE THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863165 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING PATIENT IVTM THERAPY, THE THERMOGARD IVTM SYSTEM ALARMED AND DISPLAYED AN "AIR TRAP" MESSAGE. THE SALINE BAG WAS OBSERVED ALMOST EMPTY. CUSTOMER DISCONNECTED THE QUATTRO CATHETER (LOT # 96104) FROM THE START-UP KIT (SUK), AND BLOOD TINGE WAS OBSERVED IN THE ORANGE LUER. AS PER CUSTOMER, THE PATIENT WAS ON SEVERAL BLOOD THINNER MEDICATIONS, AND THERE WAS SOME BLOOD OOZE AT THE INSERTION SITE. COMPROMISED CATHETER BALLOON WAS SUSPECTED, AND IT WAS SUGGESTED TO THE CUSTOMER TO EITHER OVER-WIRE EXCHANGE OR REPLACE THE CATHETER. HOWEVER, THE PHYSICIAN DECIDED NOT TO PLACE A NEW QUATTRO CATHETER, BUT RATHER, EXCHANGE THE QUATTRO FOR A STANDARD CVC AND CONTINUE THE THERAPY USING ALTERNATIVE METHOD. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED. NO DEVICE MALFUNCTION ON THE IN-USE TGXP THERMOGARD CONSOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417460 ↗
• MalfunctionJul 26, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY, CUSTOMER REPORTED THAT AFTER 24 HOURS INTO THE THERAPY, THE SALINE BAG HAS EMPTIED. SALINE FLUID NOTICED DRAINING FROM THE INSERTION SITE. THE QUATTRO CATHETER LOT #92029 WAS PLACED IN THE PATIENT'S RIGHT FEMORAL VEIN WITH NO DIFFICULTY. NO FLUID NOTED AROUND THE CONSOLE, FLOOR OR AROUND PATIENT'S BED. THE FACILITY NURSE DETACHED THE START-UP KIT (SUK) LOT #093404 FROM THE QUATTRO CATHETER AND RAN A CLOSED LOOP SYSTEM TO CHECK FOR LEAKAGE IN THE TUBING, NO LEAK OBSERVED. THE NURSE REPLACED THE 500ML SALINE BAG, RE-PRIMED THE TUBING, AND ATTACHED SUK BACK TO THE CATHETER. IMMEDIATELY SALINE BAG STARTED TO EMPTY AGAIN AND FLUID NOTED AT INSERTION SITE. THE QUATTRO CATHETER AND SUK WERE REPLACED TO CONTINUE THERAPY. THE IVTM THERAPY WAS COMPLETED WITH NO ISSUE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833108 ↗
• MalfunctionJan 31, 2019Use of Device Problem; Use of Device Problem

  DURING PATIENT IVTM THERAPY, THE FACILITY NURSE NOTICED THE LEVEL OF THE SALINE IN THE 500ML BAG HAS SLOWLY BEEN DEPLETING. THE PATIENT WAS HOSPITALIZED FOR POST CARDIAC ARREST AND WAS TREATED FOR THERAPEUTIC HYPOTHERMIA. THE QUATTRO CATHETER (LOT #UNKNOWN) WAS INSERTED SMOOTHLY INTO THE PATIENT'S LEFT FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN. THE NURSE CLAIMED THAT THE LEAK WAS AT THE BALLOON OF THE CATHETER. THE QUATTRO CATHETER DWELL TIME AND NOTICED OF THE ISSUE WAS BETWEEN 6-12 HOURS. NO ADJUNCT TEMPERATURE MANAGEMENT PERFORMED. THE THERMOGARD CONSOLE DID NOT ALARMED AND THE START-UP KIT SHOWED PINK-TINGED COLOR SALINE BUT HAD NO LEAK. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293499 ↗
• MalfunctionJul 26, 2018Use of Device Problem; Use of Device Problem

  APPROXIMATED 26 HOURS DURING IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AN AIRTRAP ALARM AND THE USER OBSERVED THE SALINE BAG WAS LOW. UPON FURTHER INSPECTION, THE USER OBSERVED FLUID UNDERNEATH THE CONSOLE. FOLLOWING THIS, THE USER DISCONTINUED IVTM THERAPY. THE USER WAS ABLE TO CLEAR THE AIRTRAP ALARM. ADJUNCT THERAPY WAS ADMINISTERED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725211 ↗
• MalfunctionJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS HOSPITALIZED AND IVTM THERAPY WAS INITIATED UTILIZING QUATTRO CATHETER. THE PATIENT WAS REWARMED AND WAS BEING MAINTAINED AT NORMOTHERMIA. WHEN THE CUSTOMER DID THEIR DAILY AWAKENING TRIAL ON SUNDAY, (B)(6) 2018, THE PATIENT BECAME HIGHLY AGITATED AND THRASHING AROUND IN BED. HE GOT HIS LEGS UP SO HIGH, THAT HE SNAGGED THE TUBING TO THE IVT AND PULLED THE CATHETER OUT. AFTER 2 MORE DAYS OF AWAKENING AND WEANING TRIALS, HE WAS EXTUBATED AND SEEMED NEUROLOGICALLY INTACT. HE SUBSEQUENTLY MOVED OUT OF ICU. HOWEVER, INCREASED EDEMA WAS NOTICED ON THE LEFT LEG ON SATURDAY, (B)(6) 2018, ONE DAY PRIOR TO PULLING OUT THE CATHETER ON SUNDAY. FOLLOWING DAY, AN ULTRASOUND SHOWED A DVT. THE PATIENT WAS PRESCRIBED AN ANTICOAGULANT MEDICATION, LOVENOX ON (B)(6) 2018 AND CHANGED TO ELIQUIS ON (B)(6) 2018. THE PATIENT WAS NOTED WALKING ON THE HOSPITAL FLOOR ON (B)(6) 2018, AROUND 11 AM, WHEN A CODE BLUE WAS CALLED AND THE PATIENT WAS BROUGHT DOWN TO ICU INTUBATED. THE PATIENT WAS IN CARDIAC ARREST AND A DOSE OF TPA WAS ADMINISTERED. RESUSCITATIONS CONTINUE FOR ABOUT 45 MINUTES, HOWEVER, ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NOT ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD. PER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704424 ↗
• MalfunctionJul 3, 2018Kinked; Device Issue; Kinked; Device Issue

  AS REPORTED, THE GUIDEWIRE WITH UNKNOWN LOT NUMBER WAS A BIT DIFFICULT TO PUSH BACK AFTER INSERTION OF QUATTRO CATH (LN 68874) ON THE PATIENT'S FEMORAL RIGHT SIDE. THE DWELL TIME OF THE CATHETER WAS 14 HOURS. THERAPY STARTED SUCCESSFULLY BUT AFTER FEW HOURS LATER, THE THERMOGARD XP IVTM SYSTEM WITH UNKNOWN SERIAL NUMBER TARGET TEMPERATURE COULD NOT REACHED FAST AND PRECISE. PATIENT'S TARGET TEMPERATURE WAS 33°C HOWEVER, THE PATIENT TEMPERATURE STAYED AT 36°C. X-RAY RESULTS SHOWED THAT THERE WAS A LITTLE KINK OF THE CATHETER, AND ALSO, THE RED WHEEL (FLOWINDICATOR) AT THE SUK WITH UNKNOWN LOT NUMBER WAS NOT MOVING. ADDITIONALLY, THE ROLE-PUMP GAS MOVED. NO LEAKED FLUID OBSERVED. THERE WERE NO SYSTEM ALARMS NOTICED DURING THERAPY. EXPERIENCED PRACTITIONERS HAS DECIDED TO REMOVED THE CATHETER ABOUT 14 HOURS INTO THE PATIENT THERAPY AND WAS COOLED WITH CONVENTIONAL METHODS, E.G. COOLPACKS AND SALINE. RESUSCITATION WAS THE PRIMARY CAUSE FOR THE PATIENT HOSPITALIZATION. NO INTERVENTION NEEDED OR PLANNED DUE TO THE EVENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7661557 ↗
• MalfunctionJun 21, 2018Leak/Splash; Device Issue; Device Operates Differently Than Expected; Leak/Splash; Device Issue; Device Operates Differently Than Expected

  AS REPORTED, A PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A QUATTRO CATHETER WAS PLACED IN THE PATIENT'S FEMORAL VEIN FOR THERAPEUTIC IVTM TREATMENT. THE FOLLOWING DAY, SALINE BAG FOUND TO BE EMPTY AND WAS REPLACED. NEXT DAY, PRIOR TO CATHETER REPLACEMENT, SALINE BAG AGAIN FOUND EMPTY. AT THIS POINT, LEAKAGE WAS SUSPECTED ON A QUATTRO CATHETER. NO ALARM WAS NOTED ON THE CONSOLE AND NO SALINE LEAK WAS OBSERVED ON THE PATIENT BED OR ON THE FLOOR. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626244 ↗
• MalfunctionJun 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING PATIENT THERAPY WITH THE THERMOGARD TGXP, IT WAS OBSERVED TWO BAGS OF SALINE HAD EMPTIED AND CATHETER LEAK WAS SUSPECTED. CATHETER WAS REPLACED, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO REPORT OF PATIENT IMPACT OR CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575974 ↗
• MalfunctionApr 11, 2018Leak/Splash; Device Issue; Leak/Splash; Device Issue

  THE NURSE REPORTED THAT APPROXIMATELY 6 TO 7 HOURS INTO THE IVTM TREATMENT (PATIENT COOLING), EVIDENCE OF LEAK WAS OBSERVED ON THE FLOOR AND A TINGE OF BLOOD WAS OBSERVED ON THE START-UP KIT (SUK) TUBING SUSPECTING LEAK ON THE ICY CATHETER. NO ALARM WAS OBSERVED ON THE CONSOLE. FOLLOWING THIS, THE CONSOLE WAS PLACED ON STANDBY AND 2ND ICY CATHETER LOT #77255 WAS INSERTED TO COMPLETE THE PATIENT TREATMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. RELATES TO MFR 3010617000-2018-00159 1ST ICY CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7423377 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A POST CARDIAC ARREST PATIENT WAS INSERTED A QUATTRO CATHETER WITHOUT ISSUE IN THE FEMORAL VEIN. IT WAS REPORTED BY THE HOSPITAL NURSE THAT AFTER 4 HOURS INTO IVTM TREATMENT, THE SALINE BAG WAS OBSERVED TO BE ALMOST EMPTY. THE NURSE REPLACED THE START-UP KIT AND SALINE BAG AND TREATMENT WAS RESTARTED. TWELVE HOURS INTO IVTM TREATMENT, LOSS OF THE SALINE IN THE BAG WAS NOTED AGAIN. UPON INSPECTION, NO TRACE OF BLOOD WAS OBSERVED IN THE START-UP KIT AND NO LEAKS WERE OBSERVED ON THE BED AND ON THE FLOOR. PER FOLLOW UP CALL WITH THE NURSE ON THE DUTY, 17 HOURS INTO IVTM TREATMENT, THE SALINE LEAK HAS STOPPED AND LEVEL OF SALINE IN THE BAG HAS BEEN UNCHANGED. DOCTOR DOES NOT HAVE ANY PLANS ON REPLACING THE CATHETER BECAUSE PATIENT REACHED TARGET TEMPERATURE. SINCE PATIENT NEEDS FLUID, DOCTOR IS AWARE AND NOT CONCERNED OF POSSIBILITY FOR THE ADDITIONAL SALINE GETTING INTO THE PATIENT. PER NURSE, TREATMENT HAS BEEN CONTINUE SMOOTHLY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361624 ↗
• MalfunctionMar 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST. THE QUATTRO CATHETER WAS INSERTED INTO A PATIENT'S FEMORAL VEIN ON (B)(6) 2018. THE INSERTION WAS SMOOTH. AFTER INSERTION, BLOOD WAS OBSERVED IN THE CATHETER LURED TUBING. PER CLINICAL FIELD SPECIALIST, THE USER WAS ADVISED TO REPLACE THE CATHETER OVER GUIDEWIRE. PER UPDATED INFORMATION FROM CLINICAL FIELD SPECIALIST PATIENT WAS DECLARED DECEASED ON (B)(6) 2018. PER REPORTER, PATIENT WAS TAKEN TO THE MEDICAL EXAMINER TO INVESTIGATE. PATIENT ALSO HAD A BLEEDING DISORDER WHICH THE HOSPITAL THINKS WAS THE REASON THERE WAS AN ISSUE WITH PLACING THE LINE AS THIS WOULD BE A CONTRAINDICATION. QUATTRO CATHETER WILL NOT BE RETURNED BACK FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7356200 ↗
• MalfunctionFeb 20, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A MEDWATCH REPORT MFR 2300320000-2018-8008 SUBMITTED BY THE FACILITY ON (B)(6) 2018 WAS RECEIVED BY ZOLL ON 05 FEB 2018 VIA POSTAL MAIL. THE REPORT STATES THE FOLLOWING: DUE TO A SUSPECTED CATHETER LEAK THE PATIENT WAS INSERTED A NEW ICY CATHETER (CATHETER # 2) TO CONTINUE IVTM THERAPY (THE PREVIOUS REPORT OF SUSPECTED LEAK ON THE FIRST ICY CATHETER (CATHETER # 1) IS REFERENCED UNDER (B)(4), MFR 3010617000-2018-00159). APPROXIMATELY 3.5 HOURS AFTER CATHETER PLACEMENT, THE SALINE BAG WAS OBSERVED TO BE ALMOST EMPTY AND A TINGE OF BLOOD WAS OBSERVED ON THE START-UP KIT (SUK) TUBING, THUS SUSPECTING LEAK ON THE ICY CATHETER. IVTM THERAPY WAS DISCONTINUED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7284653 ↗
• MalfunctionFeb 13, 2018Leak/Splash; Device Issue; Leak/Splash; Device Issue

  THE NURSE REPORTED THAT APPROXIMATELY 6 TO 7 HOURS INTO THE IVTM TREATMENT (PATIENT COOLING), EVIDENCE OF LEAK WAS OBSERVED ON THE FLOOR AND A TINGE OF BLOOD WAS OBSERVED ON THE START-UP KIT (SUK) TUBING SUSPECTING LEAK ON THE ICY CATHETER. NO ALARM WAS OBSERVED ON THE CONSOLE. FOLLOWING THIS, THE CONSOLE WAS PLACED ON STANDBY AND ANOTHER ICY CATHETER WAS INSERTED TO CONTINUE THE PATIENT TREATMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A MEDWATCH REPORT MFR (B)(4) SUBMITTED BY THE FACILITY ON (B)(6) 2018 WAS RECEIVED BY ZOLL ON (B)(6) 2018 VIA POSTAL MAIL. THE REPORT STATES THE FOLLOWING: "CATHETER PLACED EARLY EVENING AND COOLING INITIATED AN HOUR AND TEN MINUTES LATER. RN NOTED FLUID IN THE THERMOGARD XP SYSTEM TO BECOME RED TINGED AND IMMEDIATELY STOPPED THERAPY. NOTIFIED ICU FELLOW AT SIX HOURS AFTER COOLING WAS INITIATED AND CATHETER EXCHANGED. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." ADDITIONAL INFORMATION ON THE REPORT STATES THAT THE EVENT INVOLVED A (B)(6) FEMALE PATIENT. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7266863 ↗
• MalfunctionFeb 12, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE PATIENT WAS INSERTED A QUATTRO CATHETER AND RECEIVED IVTM THERAPY. APPROXIMATELY 12 TO 24 HOURS INTO COOLING THERAPY, THE NURSE OBSERVED BLOOD ON THE CATHETER'S LUERS. UPON INSPECTION, NO SIGN OF LEAK ON THE START-UP KIT (SUK), ON THE SALINE BAG, OR AROUND THE PATIENT'S BEDSIDE WAS OBSERVED. NO ALARM ON THE THERMOGARD CONSOLE WAS NOTED. A CATHETER LEAK WAS SUSPECTED. FOLLOWING THIS, ADJUNCT THERAPY (COOLING PADS) WAS USED TO CONTINUE THE COOLING THERAPY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7263792 ↗
• MalfunctionJan 29, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  THE PATIENT WAS INSERTED A QUATTRO CATHETER FOR IVTM THERAPY. THE USER INITIALLY EXPERIENCED DIFFICULTY INSERTING THE QUATTRO CATHETER (GETTING THE LINE IN PLACE) ON THE PATIENT. APPROXIMATELY 1 HOUR AFTER INSERTION, BLOOD WAS OBSERVED IN THE IN/OUT LUMENS OF THE CATHETER THAT CONNECTS TO THE START-UP KIT (SUK) AS WELL AS BLOOD ON THE START-UP KIT TUBING, THUS SUSPECTING A LIKELY CATHETER LEAK. FOLLOWING THIS, THE USER PLACED ANOTHER CATHETER ON THE OTHER GROIN OF THE PATIENT WITHOUT FURTHER ISSUE OBSERVED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION FROM THE MANUFACTURER'S CLINICAL FIELD REPRESENTATIVE STATED THAT THE PERSON WHO PERFORMED THE INSERTION IS EXPERIENCED WITH CATHETER PLACEMENT. THE CATHETER BALLOONS WERE NOT INFLATED PRIOR TO CATHETER PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226767 ↗