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

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00849111075121), received between Feb 25, 2016 and Apr 5, 2018 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2018Device Issue; Device Issue

  A PATIENT WAS RECEIVING INTRAVASCULAR TEMPERATURE MANAGEMENT THERAPY SINCE (B)(6) 2018. AFTER THE THIRD DAY, AN AIR TRAP ALARM WAS OBSERVED ON THE CONSOLE AND BLOOD TINGED SALINE WAS NOTED IN THE START-UP KIT (SUK). A CATHETER LEAK WAS SUSPECTED. NO KNOWN PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Missing Value Reason

  MAUDE report 7401659 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTICLE FROM AN INCIDENT RECEIVED BY (B)(6) HOSPITAL (B)(6), DEPARTMENT OF INTERNAL MEDICINE AND PUBLISHED ONLINE STATED THE FOLLOWING: A PATIENT WAS HOSPITALIZED DUE TO CARDIOPULMONARY ARREST. DURING HOSPITALIZATION, CORONARY ANGIOGRAPHY WAS PERFORMED INCLUDING PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY. A QUATTRO CATHETER WAS INSERTED ON THE PATIENT FEMORAL VEIN FOR IVTM TREATMENT. AFTER APPROXIMATELY 30 MINUTES, THE PATIENT PROGRESSIVELY DEVELOPED SEVERE HYPOTENSION. PERICARDIAL TAMPONADE WAS IDENTIFIED AND TREATED BY PERICARDIAL PUNCTURE TO CLEAR THE FLUID. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DETECTED A PERFORATION OF THE RIGHT ATRIAL ROOF BY THE QUATTRO CATHETER. OPEN SURGERY WAS IMMEDIATELY PERFORMED TO REMOVE THE CATHETER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY FURTHER COMPLICATION 10 DAYS LATER.

  Patient problems: Cardiac Perforation; Injury

  MAUDE report 7251650 ↗
• MalfunctionFeb 13, 2017Device Operational Issue; Device Operational Issue

  A PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. THE PATIENT'S TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 36.0 DEGREE CELSIUS. THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 33.0 DEGREE CELSIUS. NO OTHER ADJUNCTIVE TEMPERATURE MANAGEMENT PROCEDURES WERE PERFORMED ON THE PATIENT. A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN BY A PHYSICIAN. THE CATHETER INSERTION WAS SMOOTH. THE IN DWELL TIME OF THE CATHETER WAS 24 HOURS. AT AN UNSPECIFIED TIME DURING HYPOTHERMAL THERAPY, THE REPORTER INDICATED THE PATIENT WARMED UP; HOWEVER, THE COOLING PHASE WAS NOT NOTED. THE ATTENDING HEALTH CARE PROFESSIONAL (HCP) NOTED A FLOW DISTURBANCE WITHIN THE CATHETER. A CRINKLE IN THE CATHETER WAS SUSPECTED. THE CUSTOMER TRIED TO ASPIRATE THE CATHETER USING A SYRINGE; HOWEVER, WAS UNSUCCESSFUL. WITHOUT THE FLOW THE PATIENT COULD NOT BE COOLED, THEREFORE, THE CATHETER WAS REPLACED ON (B)(6) 2017. THERE WAS NO REPORTS OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE. THE PATIENT REMAINS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6327822 ↗
• MalfunctionFeb 2, 2017Device Issue; Device Issue

  A (B)(6) YEARS OLD FEMALE PATIENT WEIGHING (B)(6) KG AND 165 CM IN HEIGHT WAS HOSPITALIZED POST CARDIAC ARREST AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A ZOLL CATHETER WAS INSERTED BY AN EXPERIENCED INSERTING PRACTITIONER. CATHETER INSERTION WAS SMOOTH. THE IN DWELL TIME OF THE CATHETER WAS APPROXIMATELY ONE HOUR. BAIR HUGGER ADJUNCTIVE TEMPERATURE MANAGEMENT PROCEDURE WAS USED. HEMATOMA WAS NOTED BEFORE THE TEMPERATURE TREATMENT WAS INITIATED. AFTER THE QUATTRO CATHETER WAS REMOVED, THE PUNCTURE SITE WAS MANUALLY COMPRESSED. NEVERTHELESS, A HAND- SIZED HEMATOMA DEVELOPED. THE TEMPERATURE TREATMENT WAS NEVER STARTED. THE CATHETER WAS NOT REPLACED. THE PATIENT IS NOW BEING TREATED IN AN INTENSIVE CARE UNIT (ICU). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 6298865 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2015 AT 19:35 WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA, CORONARY ARTERY DISEASE, DIABETES, AND RENAL DYSFUNCTION. THE PATIENT WAS A FORMER TOBACCO USER AND NEVER USED ALCOHOL. ON (B)(6) 2015, AT 16:42, THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT A HEALTH CENTER. BEFORE EMS ARRIVAL HE RECEIVED BYSTANDER CHEST COMPRESSIONS AND DEFIBRILLATIONS. EMS ARRIVED AT 16:52, THE PATIENT WAS TREATED WITH CPR, DEFIBRILLATION AND MEDICATION. ROSC WAS ACHIEVED AT 17:00 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED ON SCENE. AT ADMISSION, A PULSE RATE OF 67 BEATS PER MINUTE, BP VALUE OF 144/69 MM HG, AND RESPIRATORY RATE OF 20 BREATHS PER MIN WERE RECORDED. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS SUCCESSFULLY INSERTED INTO THE RIGHT FEMORAL VEIN AT 19:45 AND COOLING WAS INITIATED AT 01:15. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 02:30. CATHETER WAS REMOVED ON (B)(6) 2015 AT 20:00. ON (B)(6) 2015 AT 04:00, 3 DAYS POST INITIATION OF COOLING PROCEDURE, AFTER REWARMING, DURING NORMOTHERMIA AND HEMODIALYSIS, AND 16 HOURS PRIOR TO CATHETER REMOVAL, THE PATIENT EXPERIENCED FEVER AND ARTERIAL HYP

  Patient problems: Death

  MAUDE report 6296800 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) WHITE MALE WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2015 AT 16:20 WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DYSLIPIDEMIA, CARDIOMYOPATHY, CORONARY ARTERY DISEASE (MYOCARDIAL INFARCTION IN 1995), ATRIAL FIBRILLATION, HEART FAILURE, DIABETES, RENAL DYSFUNCTION, PERIPHERAL VASCULAR DISEASE, AND BLADDER AND KIDNEY CANCER. PRIOR PCI WAS DONE ON (B)(6) 2015. THE PATIENT HAD A HISTORY OF RADICAL CYSTECTOMY AND NEPHRECTOMY FROM 1995. THE PATIENT NEVER USED TOBACCO OR ALCOHOL. ON (B)(6) 2015 AT 13:55, THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT A PUBLIC PLACE. THE PATIENT DID NOT RECEIVE ANY BYSTANDER TREATMENT. EMS ARRIVED AT 14:05. CPR AND DEFIBRILLATION WERE GIVEN AFTER EMS ARRIVAL AND ROSC WAS ACHIEVED AT 14:07 WITH AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED IN EMERGENCY DEPARTMENT. AT ADMISSION A PULSE RATE OF 60 BEATS PER MINUTE, BP VALUE OF 145/91 MM HG, AND RESPIRATORY RATE OF 14 BREATHS PER MIN WERE RECORDED. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS INSERTED SUCCESSFULLY INTO THE RIGHT FEMORAL VEIN AT 18:05 AND COOLING WAS INITIATED AT 18:14. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 19:00. CATHETER WAS REMOVED ON (B)(

  Patient problems: Death

  MAUDE report 6296786 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) FEMALE WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2015 AT 11:25 WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA. THE PATIENT WAS A CURRENT TOBACCO USER AND NEVER USED ALCOHOL. ON (B)(6) 2015 THE PATIENT HAD WITNESSED OUT OF OFFICE CARDIAC ARREST AT 08:55. BEFORE EMS ARRIVAL, SHE RECEIVED BYSTANDER CHEST COMPRESSIONS, BYSTANDER DEFIBRILLATION, 3 MG ADRENALINE AND 300 MG AMIODARONE WERE ADMINISTERED. ROSC WAS ACHIEVED AT 09:35 PRIOR TO EMS ARRIVAL WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. EMS ARRIVED AT 10:35. THE PATIENT WAS INTUBATED ON SCENE. ON ADMISSION, A PULSE RATE OF 78 BEATS PER MIN AND BP VALUE OF 110/70 MM HG WERE RECORDED. ON THE SAME DAY, IVTM ICY CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AT 11:28 SUCCESSFULLY AND COOLING WAS INITIATED AT 12:40. RE-WARMING WAS INITIATED AT 23:26. CATHETER WAS REMOVED ON (B)(6) 2015 AT 00:00. THE PATIENT WAS INTUBATED FOR 8 DAYS TILL (B)(6) 2015. AFTER CATHETER REMOVAL, IT WAS SENT FOR A CULTURE. ON (B)(6) 2015 AT 00:00, 9 DAYS POST INITIATION OF COOLING PROCEDURE AND 2 DAYS AFTER ZOLL CATHETER WAS REMOVED, INFECTION (STAPHYLOCOCCUS HOMINIS) OF A CENTRAL CATHETER WAS DIAGNOSED. THE PATIENT WAS TREATED WITH MEDICATION

  Patient problems: Bacterial Infection

  MAUDE report 6296774 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2015 AT 17:23 WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DYSLIPIDEMIA, DIABETES, RENAL DYSFUNCTION, OBESITY, AND HYPOTHYROIDISM. THE PATIENT WAS A CURRENT TOBACCO USER AND FORMERLY ALCOHOL USER. ON (B)(6) 2015 THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 15:32. BEFORE EMS ARRIVAL, HE RECEIVED BYSTANDER CHEST COMPRESSIONS AND VENTILATION AT 15:32. EMS ARRIVED AT 15:42, THE PATIENT WAS TREATED WITH CPR AND DEFIBRILLATION. ROSC WAS ACHIEVED AT 15:45 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED. AT ADMISSION, A PULSE RATE OF 63 BPM, BP OF 99/79 MM HG, AND RESPIRATORY RATE OF 18 BREATHS PER MIN WERE RECORDED. ON THE SAME DAY, ON (B)(6) 2015 AT 19:00, IVTM QUATTRO CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN SUCCESSFULLY AND COOLING WAS INITIATED. RE-WARMING WAS INITIATED ON (B)(6) 2015 AT 01:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 19:00. ON (B)(6) 2015 AT 12:00, 16 DAYS POST INITIATION OF COOLING PROCEDURE, 14 DAYS POST RE-WARMING PROCEDURE, AND 11 DAYS POST CATHETER REMOVAL, CLINICALLY NON-SIGNIFICANT SUB-SEGMENTARY THROMBOEMBOLISM WAS DIAGNOSED BY A COMPUTED TOMOGRAPHIC PULM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6296770 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FEMALE WAS ENROLLED IN THE(B)(6) STUDY ON (B)(6) 2015 AT 21:30 WITH A PAST MEDICAL HISTORY OF DEPRESSION AND ARTHROSIS. THERE IS NO KNOWN CARDIOVASCULAR MEDICAL HISTORY. PATIENT WAS A CURRENT SMOKER. ON (B)(6) 2015 PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 18:55 WITH BYSTANDER CHEST COMPRESSIONS AT 18:57 AND WAS BROUGHT INTO EMS ARRIVAL AT 19:05 WITH AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. ROSC WAS ACHIEVED AT 19:55. VITAL SIGNS WERE NOT COLLECTED AT ADMISSION. ON THE SAME DAY, IVTM CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AT 21:45 SUCCESSFULLY AND COOLING WAS INITIATED AT 23:00. ON (B)(6) AT 23:00 WHEN CONSOLE TEMPERATURE WAS 35.7 CELSIUS, VITAL SIGNS WERE COLLECTED AND BP WAS IN A LOW 94/67 MM HG. ON (B)(6) 2015, RE-WARMING INITIATED AT 01:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 00:01. ON (B)(6) 2015, 4 DAYS POST INITIATION OF COOLING PROCEDURE, DURING NORMOTHERMIA, AND A FEW HOURS POST CATHETER REMOVAL, THE PATIENT EXPERIENCED INFECTION OF THE CATHETER VASCULAR TIP -EVMT QUATTRO AT 09:41. IT WAS REPORTED TO BE DUE TO STAPHYLOCOCCUS LUGDUNENSIS AND STAPHYLOCOCCUS EPIDERMIDIS. A CULTURE WAS DONE BUT NO BACTEREMIA WAS PRESENT. EVENT WAS TREAT

  Patient problems: Unspecified Infection

  MAUDE report 6296755 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) -YEAR OLD FEMALE WAS ENROLLED IN THE FROST STUDY ON (B)(6) 2015 AT 15:26 WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, SIGNIFICANT VALVULOPATHY, MOST RECENT PCI ON (B)(6) 20016, EPISODE OF MYOCARDIAL INFARCTION ON (B)(6) 2002, HEART FAILURE, DIABETES, TRANSIENT ISCHEMIC ATTACK APPROXIMATELY 2010 (UNKNOWN DATE AND MONTH), GI BLEED IN (B)(6) 2006 AND (B)(6). THE PATIENT HAD A CARDIAC VALVE SURGERY ON (B)(6) 1974. THE PATIENT NEVER USED TOBACCO OR ALCOHOL. ON (B)(6) 2015 THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 12:57 AT HOME. BEFORE EMS ARRIVAL SHE RECEIVED BYSTANDER CHEST COMPRESSIONS AND VENTILATION AT 13:02, DEFIBRILLATIONS AT 13:03. EMS ARRIVED AT 13:25. THE PATIENT WAS INTUBATED. ROSC WAS ACHIEVED AT 13:30. AT ADMISSION A PULSE RATE OF 67 BEATS PER MINUTE, RESPIRATORY RATE OF 18 BREATHS PER MIN, AND BP VALUE OF 91/60 MM HG WERE RECORDED. ON THE SAME DAY OF (B)(6), IVTM QUATTRO CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AT 17:00 SUCCESSFULLY AND COOLING WAS INITIATED AT 20:00. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 20:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 10:00. ON (B)(6) 2015 AT 2:00, 6 HOURS POST INITIATION OF

  Patient problems: Unspecified Infection

  MAUDE report 6296709 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) -YEAR OLD MALE WAS ENROLLED IN THE FROST STUDY ON (B)(6) 2015 AT 14:51 WITH A PAST MEDICAL HISTORY OF RIB FRACTURE AND PNEUMOTHORAX. THE PATIENT NEVER USED TOBACCO OR ALCOHOL. ON (B)(6) 2015, AT 11:55, THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT A PUBLIC PLACE. BEFORE EMS ARRIVAL HE RECEIVED BYSTANDER CHEST COMPRESSIONS AT 11:57. EMS ARRIVED AT 12:09, THE PATIENT WAS TREATED WITH CPR AND DEFIBRILLATION. ROSC WAS ACHIEVED AT 12:19 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED ON SCENE. AT ADMISSION, A PULSE RATE OF 110 BEATS PER MINUTE, BP VALUE OF 135/75 MM HG, AND RESPIRATORY RATE OF 16 BREATHS PER MIN WERE RECORDED. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS SUCCESSFULLY INSERTED INTO THE RIGHT FEMORAL VEIN AT 14:30 AND COOLING WAS INITIATED AT 16:00. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 18:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 11:00. ON (B)(6) 2015 AT 09:00, 3 DAYS POST INITIATION OF COOLING PROCEDURE, DURING NORMOTHERMIA MAINTENANCE, THE PATIENT SYMPTOMS OF THE PATIENT'S POST-ANOXIC ENCEPHALOPATHY GOT WORSENED. THE SITE REPORTED THAT THE EVENT WAS SERIOUS (RESULTED IN SIGNIFICANT DISABILITY OR INCAPACITY AND REQU

  Patient problems: Death

  MAUDE report 6296687 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) WHITE MALE WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2015 AT 21:30 WITH A PAST MEDICAL HISTORY OF SIGNIFICANT VALVULOPATHY, HEART FAILURE, ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STEINERT'S DISEASE, ZOSTER HERPES, COLONIC RESECTION, POLYCYTHEMIA, AND CARDIAC VALVE SURGERY. THE PATIENT WAS A FORMER TOBACCO USER AND NEVER USED ALCOHOL. ON (B)(6) 2015 THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 19:50. BEFORE EMS ARRIVAL, HE RECEIVED BYSTANDER CHEST COMPRESSIONS. EMS ARRIVED AT 19:55. THE PATIENT RECEIVED EMS TREATMENT WITH CPR, DEFIBRILLATION AND MEDICATION. ROSC WAS ACHIEVED AFTER EMS ARRIVAL AT 20:35 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED ON SCENE. ON ADMISSION, A PULSE RATE OF 80 BEATS PER MIN AND BP VALUE OF 125/65 MM HG WERE RECORDED. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS INSERTED SUCCESSFULLY INTO THE RIGHT FEMORAL VEIN AT 22:00 AND COOLING WAS INITIATED FEW MINUTES LATER. RE-WARMING PROCEDURE WAS INITIATED AT ON (B)(6) 2015 AT 10:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 02:55. ON (B)(6) 2015, AT 00:00, 2 HOURS POST INITIATION OF COOLING PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA. DU

  Patient problems: Death

  MAUDE report 6296646 ↗
• MalfunctionFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) WHITE MALE WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2015 AT 15:30. THERE WAS NO KNOWN CARDIOVASCULAR MEDICAL HISTORY. THE PATIENT WAS A FORMER SMOKER WITH NO KNOWN HISTORY OF ALCOHOL USE. ON (B)(6) 2015 THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 13:10 WITH BYSTANDER CHEST COMPRESSIONS AT 13:12 AND BYSTANDER DEFIBRILLATION AT 13:15. THE PATIENT WAS BROUGHT INTO EMS ARRIVAL AT 13:30 WITH AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. ROSC WAS ACHIEVED AT 13:47. THE PATIENT WAS INTUBATED ON (B)(6) 2015. ON ADMISSION, A PULSE RATE OF 105 BEATS PER MIN, RESPIRATORY RATE OF 15 BREATHS PER MIN, AND BP VALUE OF 60/50 MM HG WERE RECORDED. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN AT 18:00 SUCCESSFULLY AND COOLING WAS INITIATED. RE-WARMING WAS INITIATED AT 21:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 19:00. ON (B)(6) 2015 AT 23:59 LESS THAN 24 HOURS POST INITIATION OF COOLING PROCEDURE AND 24 HOURS PRIOR TO REWARMING PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION, FOR WHICH 3 SHOCKS WERE ADMINISTERED. THE PATIENT ALSO WAS TREATED WITH ADRENALINE AND ATROPINE AND RETURNED TO ROSC ON (B)(6) 2015 AT 00:08. EVENT WA

  Patient problems: Atrial Fibrillation

  MAUDE report 6296621 ↗
• MalfunctionDec 22, 2016Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR POST CARDIAC ARREST AND REQUIRED THERAPEUTIC HYPOTHERMIA. THE QUATTRO CATHETER WAS PLACED IN A PATIENT. DURING MAINTENANCE PHASE IT WAS FOUND THAT THE SALINE BAG RAN DRY BLOOD RETURN IN LINE. IT WAS ASSUMED THAT THE CATHETER WAS LEAKED. THE SYSTEM WAS SWITCHED IN STANDBY MODE AND THE CATHETER WAS KEPT INSIDE THE PATIENT FOR CENTRAL ACCESS USE. THE BLANKET WAS PERFORMED ON THE PATIENT INSTEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD EXPIRED .PER REPORTER, THE HEROIN OVERDOSE THAT LED TO CARDIAC ARREST AND THE DEATH WAS NOT ATTRIBUTED TO THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6199863 ↗
• MalfunctionNov 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD MALE PATIENT WEIGHING (B)(6) UNDERWENT TREATMENT FOR HYPOTHERMIA AFTER A CARDIAC ARREST. THE PATIENT'S TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 36.3 DEG C. THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 33 DEG C NO OTHER ADJUNCTIVE TEMPERATURE MANAGEMENT PROCEDURES WERE PERFORMED ON THE PATIENT. THERE WAS NO SEPARATE CATHETER USED FOR THE CENTRAL LINE. PATIENT WAS STARTED ON 10.000 IE/ML HEPARIN PER DAY. A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN ON AN UNSPECIFIED DATE. CATHETER INSERTION WAS SMOOTH AND WAS PERFORMED IN ONE ATTEMPT. THE WARMING RATE WAS SET TO 0.15 DEG C AND THE PATIENT WAS BEING WARMED FROM 36 DEG C. THE IVTM CONSOLE RAN IN THE WARMING MODE FOR 24 HOURS. DURING PATIENT'S TEMPERATURE MANAGEMENT THERAPY, THERE WERE NO SYSTEM ALARMS NOTED AND NO LEAKS OBSERVED. THE DWELL TIME OF THE CATHETER WAS 4 DAYS AND WAS NOT REPLACED. DURING AN ULTRASOUND (DATE NOT SPECIFIED) A DEEP VEIN THROMBOSIS (DVT) WAS OBSERVED IN THE INFERIOR VENA CAVA. THE PATIENT WAS NOT IN A HIGH RISK FOR DVT. THE PATIENT WAS TREATED WITH ANTICOAGULATION (LYSIS). NO OTHER ADJUNCT PROCEDURES WERE PERFORMED ON THE PATIENT. THERE WERE NO VESSEL INJURIES

  Patient problems: Patient Problem/Medical Problem; Thrombosis

  MAUDE report 6097825 ↗
• InjuryNov 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016 AT 5PM, A (B)(6) FEMALE PATIENT WEIGHING (B)(6), SUFFERED A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT ARRIVED AT THE HOSPITAL AT 6:43PM VIA EMERGENCY MEDICAL SERVICES. THE PATIENT'S TEMPERATURE (AT 7PM) PRIOR TO THE IVTM THERAPY WAS 37.1°C. ANTI-SHIVERING MEDICATION WAS ADMINISTERED BEFORE COOLING TEMPERATURE MANAGEMENT BEGAN. THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 32°C. A ZOLL QUATTRO CATHETER WAS INSERTED AT 7:10PM, INTO THE LEFT FEMORAL VEIN. FOLLOWING THE INSERTION OF THE CATHETER, IT WAS REPORTED THAT AT 7:16PM, THE PATIENT EXPERIENCED A VENTRICULAR FIBRILLATION (VF). THE PATIENT RECEIVED A SHOCK AND THE EVENT ENDED A MINUTE LATER. THE EVENT WAS REPORTED TO HAVE BEEN RESOLVED WITHOUT SEQUELAE. IT WAS REPORTED THAT IT POSSIBLE THAT THE GUIDEWIRE COULD HAVE TOUCHED THE RIGHT SIDE OF THE PATIENT'S HEART, CONTRIBUTING TO THE ARRHYTHMIA. IT WAS ALSO NOTED THAT THE EVENT COULD HAVE BEEN RELATED TO THE PATIENT'S ACUTE ANTERIOR STEMI. AT 9:04PM THAT EVENING, THE PATIENT REACHED TARGET TEMPERATURE. CATHETER WAS REMOVED ON (B)(6) 2016, AT 12:30PM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6091601 ↗
• MalfunctionJul 20, 2016Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS PLACED IN PATIENT WITHOUT ANY DIFFICULTY. HOWEVER; BLOOD WAS NOTED IN TUBING WHEN THE COOLING THERAPY WAS INITIATED. CATHETER WAS REPLACED AND NO HARM WAS NOTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5809450 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WAS ENROLLED IN THE (B)(6) STUDY. THE PATIENT'S CONDITION AT ENROLLMENT WAS COMATOSE AFTER CARDIAC ARREST FOUND IN VENTRICULAR FIBRILLATION. ZOLL QUATTRO IVTM CATHETER WAS INSERTED ON (B)(6) 2015 @ 22:03. COOLING INITIATED ON (B)(6) 2015 @ 23:39. RE-WARMING INITIATED ON (B)(6) 2015 @ 04:00. NORMOTHERMIA WAS ACHIEVED ON (B)(6) 2015 @ 16:00. THE PATIENT EXPERIENCED ADVERSE EVENT 1: INFECTION-PNEUMONIA, WHICH OCCURRED ON (B)(6) 2015 @ 12:15 AT THE END OF REWARMING AND STOPPED ON (B)(6) 2015, 9 DAYS AFTER CATHETER REMOVAL. EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE RESPIRATORY THERAPIST REPORTED THAT THE PATIENT WAS NOTED TO HAVE THICK TAN/GREEN SPUTUM, WHICH WAS THEN SENT FOR CULTURE. CHEST X-RAY REVEALED A RETROCARDIAC AIRSPACE OPACITY THAT COULD REPRESENT ATELECTASIS, ASPIRATION OR PNEUMONIA. THE SPUTUM CULTURE DID NOT GROW ANYTHING BACTERIAL; HOWEVER, IT DID SUGGEST H. INFLUENZAE. THE DECISION WAS MADE BY THE HEALTH CARE TEAM TO TREAT WITH BROAD SPECTRUM ANTIBIOTICS. THE PATIENT WAS ON EXTUBATED ON (B)(6) 2015 AND RE-INTUBATED ON (B)(6) 2015 FOR AIRWAY PROTECTION. EVENT REPORTED BY INVESTIGATOR AS A MAJOR ADVERSE EVENT THAT REQUIRED TREATMENT TO PREVENT PERMANEN

  Patient problems: Pneumonia; Ventricular Tachycardia

  MAUDE report 5693550 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD WHITE MALE WITH AN OHCA SECONDARY TO VENTRICULAR FIBRILLATION. COOLING WAS INITIATED AND PATIENT WAS ENROLLED INTO THE STUDY AFTER INFORMED CONSENT WAS OBTAINED. ZOLL QUATTRO IVTM CATHETER WAS INSERTED ON RIGHT FEMORAL VEIN ON (B)(6) 2015 @ 1549. COOLING INITIATED AT (B)(6) 2015 @1700, REWARMING STARTED (B)(6) 2015@ 1800, AND NORMOTHERMIA WAS REACHED (B)(6) 2015 @13:00. CATHETER WAS REMOVED ON (B)(6) 2015 @ 14:40H. THE PATIENT EXPERIENCED AN ADVERSE EVENT: ILEUS WHICH BEGAN ON (B)(6) 2015 @1015. THE EVENT WAS REPORTED AS NOT SERIOUS, NOT DEVICE OR TREATMENT RELATED, AND NOT ANTICIPATED COMPLICATION. HOWEVER, IT WAS REPORTED TO BE RELATED TO CLINICAL CONDITION. EVENT REQUIRED TREATMENT OF MANUAL DISIMPACTION AND ADMINISTRATION OF MEDICATION. ILEUS WAS RESOLVED WITH SEQUELAE ON (B)(6) 2015 @ 06:55. THE INVESTIGATOR ESTABLISHED THAT THERE WAS NO RELATIONSHIP BETWEEN THE REPORTED EVENT WITH THE DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED ON DOCUSATE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5693547 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WAS ENROLLED INTO THE (B)(6) STUDY. PATIENT WAS BROUGHT TO THE ENROLLING FACILITY ON (B)(6) 2015 VIA EMERGENCY MEDICAL SERVICES AFTER SUFFERING FROM A CARDIAC ARREST WITH AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. PATIENT'S CONDITION AT ENROLLMENT WAS COMATOSE POST CARDIAC ARREST SECONDARY TO "MASSIVE MI" PER HISTORY AND PHYSICAL. ZOLL QUATRO IVTM CATHETER WAS INSERTED ON (B)(6) 2015 AT 12:44H IN RIGHT FEMORAL VEIN. COOLING INITIATED ON (B)(6) 2015 AT 13:57H. TARGET TEMPERATURE ACHIEVED ON (B)(6) 2015 AT 06:00H. REWARMING INITIATED ON (B)(6) 2015 AT 06:00H. NORMOTHERMIA ACHIEVED ON AT (B)(6) 2015 AT 18:00H. THE PATIENT EXPERIENCED ADVERSE EVENT 1, INFECTION-PNEUMONIA, WHICH BEGAN ON (B)(6) 2015 AT AN UNKNOWN TIME, DURING THE NORMOTHERMIA/MAINTENANCE PHASE. INFECTION-PNEUMONIA WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015 AT AN UNKNOWN TIME. EVENT REPORTED BY INVESTIGATOR AS NOT SERIOUS, WITH A CTCAE GRADE OF 2, UNRELATED TO THE DEVICE OR PROCEDURE, UNRELATED TO THE SUBJECT'S CLINICAL CONDITION AND ANTICIPATED. EVENT REQUIRED CHANGE OF EXISTING MEDICATIONS. THE PATIENT WAS INTUBATED. CATHETER WAS REMOVED ON (B)(6) 2015 AT 12:00H. BASED ON RADIOLOGISTS REPORTS, THE I

  Patient problems: Pneumonia

  MAUDE report 5693544 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD WHITE FEMALE WAS ENROLLED INTO THE (B)(6) STUDY. PATIENT CONDITION AT ENROLLMENT WAS COMATOSE AFTER CARDIAC ARREST WITH AN INITIAL RHYTHM OF "NO SHOCK ADVISED". ZOLL QUATTRO IVTM CATHETER WAS INSERTED ON (B)(6) 2015 AT 10:10. COOLING INITIATED ON (B)(6) 2015 AT 10:21. TARGET TEMPERATURE ACHIEVED ON (B)(6) 2015 AT 11:05. THE PATIENT EXPERIENCED ADVERSE EVENT 1: INFECTION-PNEUMONIA, WHICH OCCURRED ON: (B)(6) 2015 AT 06:47. THE PATIENT WAS INTUBATED WHEN THE ADVERSE EVENT WAS DISCOVERED. EVENT REQUIRED CHANGE OF EXISTING MEDICATIONS. THE EVENT WAS REPORTED AS SERIOUS, WITH A CTCAE GRADE OF 3, NOT RELATED TO THE DEVICE OR PROCEDURE, AND RELATED TO THE PATIENT'S CLINICAL CONDITION AND ANTICIPATED. REWARMING INITIATED ON (B)(6) 2015 AT 13:00. NORMOTHERMIA ACHIEVED ON (B)(6) 2015 AT 18:00. THE PATIENT EXPIRED ON (B)(6) 2015 AT 01:30. THE EVENT OUTCOME WAS ONGOING AT THE TIME OF DEATH. ADVERSE EVENT ONSET OCCURRED APPROXIMATELY 52 HOURS PRIOR TO QUATTRO CATHETER REMOVAL. CATHETER WAS REMOVED ON (B)(6) 2015 AT 13:30. THE INVESTIGATOR REPORTED INFECTION-PNEUMONIA AS NOT RELATED TO STUDY DEVICE MALFUNCTIONS.

  Patient problems: Pneumonia

  MAUDE report 5693543 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WAS ENROLLED IN THE (B)(6) STUDY. PATIENT CONDITION AT ENROLLMENT WAS COMATOSE AFTER CARDIAC ARREST FOUND IN VENTRICULAR FIBRILLATION. ZOLL QUATTRO CATHETER WAS INSERTED ON (B)(6) 2015@ 15:54H IN THE RIGHT FEMORAL VEIN. THE PATIENT EXPERIENCED ADVERSE EVENT: EXCESSIVE BLEEDING, WHICH OCCURRED ON (B)(6) 2015@ 1656H DURING HYPOTHERMIA AND WAS INTERMITTENT. PER THE INVESTIGATION, THE PATIENT'S EXCESSIVE BLEEDING AT THE RIGHT GROIN WAS SECONDARY TO INTEGRILIN. INTEGRILIN STOPPED, FEMSTOP/COMPRESSION APPLIED AT THE SITE. OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015@ 17:39H. EVENT REPORTED AS NOT SERIOUS BY INVESTIGATOR, NOT RELATED TO DEVICE OR PROCEDURE, WAS NOT RELATED TO THE PATIENT'S CLINICAL CONDITION, WAS NOT RELATED TO TREATMENT, AND WAS ANTICIPATED. THE INVESTIGATOR REPORTED EVENT AS NOT RELATED TO STUDY DEVICE MALFUNCTIONS. COOLING INITIATED ON (B)(6) 2015 @ 18:30H. REWARMING INITIATED ON (B)(6) 2015@ 19:00H. NORMOTHERMIA WAS ACHIEVED ON (B)(6) 2015@ 03:00H. THE PATIENT EXPERIENCED ADVERSE EVENT: INFECTION-OTHER URINARY TRACT INFECTION, WHICH OCCURRED ON (B)(6) 2015@ 15:21 AFTER NORMOTHERMIA WAS ACHIEVED AND WAS NOT INTERMITTENT. OUTCOME WAS ONGOING AT THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 5693540 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) YEAR OLD WHITE MALE WAS ENROLLED IN THE (B)(6) STUDY. PATIENT CONDITION AT ENROLLMENT WAS COMATOSE AFTER CARDIAC ARREST FOUND IN VENTRICULAR FIBRILLATION. ZOLL QUATTRO CATHETER WAS INSERTED ON (B)(6) 2014 @ 13:52H IN THE LEFT FEMORAL VEIN. COOLING INITIATED ON (B)(6) 2014 @14:54H. REWARMING INITIATED ON (B)(6) 2014@23:44H. THE PATIENT EXPERIENCED ADVERSE EVENT 1: CLINICALLY SIGNIFICANT HEMATOMA, WHICH OCCURRED ON (B)(6) 2014 @ 20:31 DURING HYPOTHERMIA AND WAS NOT INTERMITTENT. OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014@ 08:00H. EVENT REPORTED AS SERIOUS BY INVESTIGATOR-LIFE THREATENING, NOT RELATED TO DEVICE OR PROCEDURE, WAS RELATED TO THE PATIENT'S CLINICAL CONDITION, WAS RELATED TO TREATMENT -COOLING AND ADJUNCTIVE PROCEDURE AND WAS ANTICIPATED. SUBJECT RECEIVED MANUAL AND MECHANICAL PRESSURE AT SITE, ADMINISTRATION OF, OR CHANGE TO MEDICATIONS AND PROLONGED HOSPITALIZATION. NORMOTHERMIA WAS ACHIEVED ON (B)(6) 2014@15:30H. CATHETER WAS REMOVED ON (B)(6) 2015@ (B)(6) 2014@2313H. THE INVESTIGATOR REPORTED THE EVENT AS NOT RELATED TO STUDY DEVICE MALFUNCTIONS. PER THE INVESTIGATION, THE PATIENT HAD A HEMATOMA/BLEEDING ISSUE ON BOTH CATHETER (A-LINE IN RIGHT GROIN A

  Patient problems: Hematoma

  MAUDE report 5693532 ↗
• MalfunctionMay 6, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PATIENT USE THE QUATTRO CATHETER MAY HAVE A LEAK. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). IVTM (INTRAVENOUS TEMPERATURE MANAGEMENT) THERAPY WAS STARTED. A QUATTRO CATHETER WAS INSERTED INTO THE PATIENT. THE INSERTION WAS SMOOTH, WITHOUT ISSUE. SHORTLY AFTER THE TREATMENT STARTED THE ER STAFF NOTICED THAT 1.5 LITERS OF SALINE WAS GONE FROM THE SALINE BAG. THERE WAS NO FLUID ON THE FLOOR OR UNDER THE PATIENT. NO PATIENT SEQUELAE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5638906 ↗
• MalfunctionApr 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 AT 23:45 A ZOLL QUATTRO CATHETER WAS PLACED SUCCESSFULLY IN THE FEMORAL VEIN. THE PATIENT WAS HAVING A PROCEDURE IN THE CATH LAB. AT THE END OF THE PROCEDURE, THE QUATTRO CATHETER WAS DISCONNECTED FROM THE START-UP KIT (SUK) AND BOTH GREEN (IN AND OUT) PORTS OF THE QUATTRO CATHETER WERE CONNECTED AND BOTH ENDS OF THE SUK TUBING WERE RECONNECTED TO BECOME A CLOSED SYSTEM AGAIN. THE PATIENT AND IVTM SYSTEM WERE TRANSFERRED TO THE ICU WHERE THE PHYSICIAN WANTED TO RECONNECT THE GREEN PORTS TO THE SUK AGAIN. HE OPENED THE SUK TUBING BUT COULD NOT RECONNECT BOTH ENDS TO THE APPROPRIATE GREEN PORT OF THE QUATTRO CATHETER. A NEW SUK WHICH WAS PREPPED ACCORDING TO THE INSTRUCTIONS AND THIS ONE WAS CONNECTED TO THE QUATTRO CATHETER WITHOUT ANY ISSUES. THE PHYSICIAN BELIEVES THAT HE PUT TOO MUCH POWER DURING THE CLOSURE OF THE SUK TUBES IN THE CATH LAB THAT THE DAMAGES THE LUER LOCK SYSTEM. ON (B)(6) 2016 AT 08:00, THE QUATTRO CATHETER WAS REMOVED. AFTER REMOVAL OF THE CATHETER FROM THE FEMORAL VEIN, MINOR BLEEDING WAS NOTED AT THE ACCESS SITE WHICH WAS TREATED WITH SUPERFICIAL BANDAGE. THE BLEEDING WAS RESOLVED WITHOUT ANY SEQUELAE.

  Patient problems: No Code Available

  MAUDE report 5586087 ↗