SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EU SL-2593AERecalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00849111075312), received between Apr 10, 2017 and Aug 25, 2026 — classified as 2 deaths, 17 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (49 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Difficult to Insert; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435656 ↗
• InjuryApr 21, 2026Fluid/Blood Leak; Material Integrity Problem

  A 77-YEAR-OLD MALE PATIENT WEIGHING 90 KG WAS RECEIVING IVTM THERAPY FOR POST-CPR HYPOTHERMIA USING A SOLEX 7 CATHETER (LOT #214144). THE CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN WITH A SMOOTH, SINGLE-ATTEMPT INSERTION. IT WAS POSITIONED AT 16 CM. NOREPINEPHRINE WAS INFUSED THROUGH THE CATHETER'S INFUSION LUMEN. AFTER 24 HOURS, THE PATIENT EXHIBITED SIGNIFICANT FLUCTUATIONS IN CATECHOLAMINE LEVELS WITHOUT ANY CHANGE IN FLOW RATE. OVER TIME, IT WAS OBSERVED THAT THE CATHETER INSERTION SITE ON THE NECK WAS SLIGHTLY SWOLLEN, AND THE SWELLING CONTINUED TO WORSEN. THE CUSTOMER NOTED LEAKED FLUID AT THE PUNCTURE SITE. ACCORDING TO THE CUSTOMER, IT CANNOT BE CONFIRMED WHETHER THE LEAKED FLUID WAS MEDICATION; HOWEVER, THIS IS ASSUMED DUE TO THE BLOOD PRESSURE FLUCTUATIONS. THERE WAS ALSO SUSPICION OF A SALINE LEAK, BUT A REDUCTION IN SALINE SOLUTION WAS NOT CONFIRMED. THE SWOLLEN AREA WAS COOLED LOCALLY TO REDUCE SWELLING. NO IMAGING WAS PERFORMED TO VERIFY THE CATHETER'S CORRECT POSITION, AND THE PATIENT WAS NOT MOVED OR TRANSPORTED BEFORE THE ISSUE WAS REPORTED. THE PATIENT'S TEMPERATURE AT THE START OF IVTM THERAPY WAS 35.6°C, WITH A TARGET OF 36°C AT THE MAX

  Patient problems: Swelling/ Edema

  MAUDE report 24941578 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A 66-YEAR-OLD MALE PATIENT. THE PRIMARY CAUSE OF HOSPITALIZATION AND THE NEED FOR IVTM THERAPY WAS HYPOTHERMIA FOLLOWING CARDIAC ARREST. THE SOLEX 7 CATHETER (LOT # 213627) WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN WITHOUT DIFFICULTY. AFTER TWO HOURS OF IVTM THERAPY, A CATHETER LEAK WAS SUSPECTED. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580076 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2026, AT APPROXIMATELY 18:00, A SOLEX CATHETER (LOT # 209953) WAS SUCCESSFULLY INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN ON THE FIRST ATTEMPT WITH NO COMPLICATIONS. HYPOTHERMIA THERAPY WAS INITIATED AND CONTINUED UNTIL (B)(6) 2026. AT APPROXIMATELY 10:00 ON (B)(6) AN AIR TRAP ALARM WAS TRIGGERED. UPON INSPECTION, THE NURSE OBSERVED THAT THE SALINE IN BOTH THE CATHETER AND THE START-UP KIT (SUK) TUBING HAD TURNED PINK. WHILE THE 500 ML SALINE BAG WAS IN USE, THE PHYSICIAN SUSPECTED A BALLOON RUPTURE AND ESTIMATED THAT 200 CC OR LESS OF SALINE HAD BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM. BECAUSE BLOOD WAS VISIBLE IN THE SALINE LOOP, THE PHYSICIAN OPTED NOT TO PERFORM A MANUAL LEAK CHECK PER THE IFU AND IMMEDIATELY REPLACED THE CATHETER AND SUK. THE THERMOGARD CONSOLE REMAINED IN USE AND WAS FOUND TO BE FULLY FUNCTIONAL, AS TREATMENT CONTINUED WITHOUT FURTHER INTERRUPTION ONCE THE DISPOSABLES WERE REPLACED. THERE WERE NO REPORTED ISSUES WITH THE SUK ITSELF, AND NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447456 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A 56-YEAR-OLD MALE PATIENT. THE PRIMARY CAUSE OF HOSPITALIZATION AND THE NEED FOR IVTM THERAPY WAS HYPOTHERMIA FOLLOWING CPR. THE SOLEX 7 CATHETER (LOT # 204764) WAS INSERTED INTO THE LEFT INTERNAL JUGULAR VEIN WITHOUT DIFFICULTY. ON THE FOURTH DAY OF IVTM THERAPY, WHILE THE PATIENT WAS UNDER ONGOING SEDATION, A FLUID LEAK AT THE CATHETER INSERTION SITE WAS NOTED. THE CATHETER DWELL TIME WAS 4 DAYS AND 2 HOURS. THE CATHETER WAS REMOVED AND REPLACED WITH A STANDARD CENTRAL VENOUS CATHETER. THE IVTM THERAPY HAD ALREADY BEEN COMPLETED AT THAT TIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445850 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED A LOSS OF SALINE DURING IVTM THERAPY FOR A 67-YEAR-OLD 85 KG MALE PATIENT. A BALLOON LEAKAGE WAS SUSPECTED ON THE SOLEX CATHETER (LOT 207977). APPROXIMATELY 200 ML OF SALINE INFUSION INTO THE PATIENT WAS SUSPECTED. THE CATHETER HAS BEEN INSERTED INTO THE LEFT INTERNAL JUGULAR SITE SMOOTHLY ON THE FIRST ATTEMPT. THE DWELL TIME WAS 56 HOURS. THE CATHETER WAS REMOVED AND REPLACED. SUBSEQUENTLY THE SALINE BAG WAS REPLACED, PER IFU. THE SAME CONSOLE WAS USED TO CONTINUE THERAPY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369291 ↗
• MalfunctionDec 11, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE SOLEX CATHETER (LOT# 212068) WAS INSERTED VIA THE RIGHT JUGULAR VEIN, AND HYPOTHERMIA THERAPY BEGAN AT 16:50 ON (B)(6) 2025. THE FOLLOWING DAY, THE THERMOGARD CONSOLE TRIGGERED AN AIR TRAP ALARM. UPON INSPECTION, THE NURSE NOTED THAT APPROXIMATELY 100 CC OF SALINE REMAINED IN THE BAG, AND THE SALINE WITHIN THE CATHETER HAD TURNED LIGHT PINK, SUGGESTING A POSSIBLE CATHETER LEAK. A CATHETER BALLOON LEAK CHECK WAS PERFORMED, CONFIRMING THE ISSUE. THE SOLEX CATHETER WAS SUBSEQUENTLY REPLACED TO CONTINUE THE TREATMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785932 ↗
• InjuryNov 28, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A POST-CARDIAC ARREST PATIENT RECEIVED IVTM THERAPY WITH THE SOLEX 7 CATHETER (LOT # 206518). THE CATHETER WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN IN A SINGLE INSERTION ATTEMPT BY THE SENIOR ATTENDING PHYSICIAN. NO OTHER LINE WAS PLACED IN THE SAME VEIN. AFTER PLACEMENT, AN X-RAY CONFIRMED THE CATHETER'S CORRECT POSITION. MEDICATIONS ADMINISTERED THROUGH THE INFUSION LUMEN INCLUDED SUFENTANIL, MIDAZOLAM, NORMOFUNDIN, HEPARIN, NORADRENALINE, AND JONOSTERIL. FOLLOWING INDUCTION OF THERAPEUTIC HYPOTHERMIA TO 34.5 °C, THE PATIENT WAS GRADUALLY REWARMED AT A RATE OF 0.25 °C PER HOUR UNTIL REACHING 36.5 °C. ONCE THE TARGET TEMPERATURE WAS REACHED, THE SYSTEM WAS SET TO MAINTAIN IT. THE THERMOGARD CONSOLE DID NOT TRIGGER ANY ALARMS DURING THERAPY. WHILE MAINTAINING THE TARGET TEMPERATURE, IT WAS OBSERVED THAT THE 500-ML SALINE BAG WAS PARTIALLY DEPLETED, AND THE PATIENT'S NECK BECAME INCREASINGLY SWOLLEN AT THE CATHETER INSERTION SITE. THERE WAS NO SALINE EVIDENCE ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR THE FLOOR. THE PATIENT HAD BEEN REPOSITIONED ONCE IN THE CARDIAC CATHETERIZATION LAB (CATH LAB) THREE DAYS PRIOR TO THE INCIDENT. NO SUBCUTANEOUS DRUG

  Patient problems: Swelling/ Edema

  MAUDE report 23674534 ↗
• MalfunctionNov 26, 2025Difficult to Remove; Difficult to Remove

  THE USER EXPERIENCED DIFFICULTY DURING THE ATTEMPTED REMOVAL OF THE INITIAL SOLEX 7 CATHETER (LOT# 214426); THE ROTATIONAL MANIPULATION CAUSED THE BALLOON TO RUPTURE. DUE TO THE CATHETER'S TIME LIMIT EXPIRING, A SECOND SOLEX 7 CATHETER (LOT# 214426) WAS INSERTED; HOWEVER, IT BECAME ENTANGLED WITH THE CATHETER'S HEAT EXCHANGER BALLOONS, COMPLICATING ITS REMOVAL. BOTH CATHETERS WERE REMOVED, AND A THIRD CATHETER WAS PLACED TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662791 ↗
• MalfunctionNov 26, 2025Difficult to Remove; Difficult to Remove

  THE USER EXPERIENCED DIFFICULTY DURING THE ATTEMPTED REMOVAL OF THE INITIAL SOLEX 7 CATHETER (LOT# 214426); THE ROTATIONAL MANIPULATION CAUSED THE BALLOON TO RUPTURE. DUE TO THE CATHETER'S TIME LIMIT EXPIRING, A SECOND SOLEX 7 CATHETER (LOT# 214426) WAS INSERTED; HOWEVER, IT BECAME ENTANGLED WITH THE CATHETER'S HEAT EXCHANGER BALLOONS, COMPLICATING ITS REMOVAL. BOTH CATHETERS WERE REMOVED, AND A THIRD CATHETER WAS PLACED TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662789 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  THE SOLEX 7 CATHETER (LOT # 204764) WAS INSERTED INTO THE PATIENT'S RIGHT JUGULAR VEIN TO INITIATE IVTM THERAPY TO INDUCE THERAPEUTIC HYPOTHERMIA. THE CATHETER REMAINED IN PLACE WITHOUT ISSUES FOR SEVEN DAYS BUT NEEDED TO BE REPLACED TO CONTINUE TREATMENT DUE TO THE PATIENT'S PERSISTENT FEVER. FIRST, ANOTHER SOLEX 7 CATHETER (LOT # 204764) WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S LEFT JUGULAR VEIN, OPPOSITE THE INITIAL SITE. BOTH THE GUIDEWIRE AND THE SECOND CATHETER ADVANCED SMOOTHLY. AFTER PLACING THE SECOND CATHETER, THE CUSTOMER ATTEMPTED TO REMOVE THE FIRST SOLEX 7 CATHETER. THE REMOVAL WAS SIGNIFICANTLY DIFFICULT AS THE CATHETER'S BALLOON WAS PARTIALLY DETACHED AND TORN AT ONE LOCATION. NOTABLY, SIMILAR TEARS WERE OBSERVED ON BOTH SIDES OF THE CATHETER. IT APPEARED THAT THE BALLOONS OF THE TWO CATHETERS MAY HAVE BECOME ENTANGLED OR HOOKED TOGETHER, CAUSING THE FIRST CATHETER'S BALLOON TO DETACH FROM THE SHAFT DURING REMOVAL. IT WAS CONFIRMED THAT THE CUSTOMER USED A SYRINGE TO REMOVE SALINE FROM THE CATHETER BALLOON BEFORE REMOVING THE CATHETER. THE (OUT) LUER OF THE CATHETERS WAS CLAMPED BEFORE THE VACUUM FROM THE SYRINGE WAS APPLIED TO THE (IN) LUER. ADDITIONALLY, THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373437 ↗
• MalfunctionOct 23, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  THE SOLEX 7 CATHETER (LOT # 204764) WAS INSERTED INTO THE PATIENT'S RIGHT JUGULAR VEIN TO INITIATE IVTM THERAPY TO INDUCE THERAPEUTIC HYPOTHERMIA. THE CATHETER REMAINED IN PLACE WITHOUT ISSUES FOR SEVEN DAYS BUT NEEDED TO BE REPLACED TO CONTINUE TREATMENT DUE TO THE PATIENT'S PERSISTENT FEVER. FIRST, ANOTHER SOLEX 7 CATHETER (LOT # 204764) WAS SUCCESSFULLY INSERTED INTO THE PATIENT'S LEFT JUGULAR VEIN, OPPOSITE THE INITIAL SITE. BOTH THE GUIDEWIRE AND THE SECOND CATHETER ADVANCED SMOOTHLY. AFTER PLACING THE SECOND CATHETER, THE CUSTOMER ATTEMPTED TO REMOVE THE FIRST SOLEX 7 CATHETER. THE REMOVAL WAS SIGNIFICANTLY DIFFICULT AS THE CATHETER'S BALLOON WAS PARTIALLY DETACHED AND TORN AT ONE LOCATION. NOTABLY, SIMILAR TEARS WERE OBSERVED ON BOTH SIDES OF THE CATHETER. IT APPEARED THAT THE BALLOONS OF THE TWO CATHETERS MAY HAVE BECOME ENTANGLED OR HOOKED TOGETHER, CAUSING THE FIRST CATHETER'S BALLOON TO DETACH FROM THE SHAFT DURING REMOVAL. IT WAS CONFIRMED THAT THE CUSTOMER USED A SYRINGE TO REMOVE SALINE FROM THE CATHETER BALLOON BEFORE REMOVING THE CATHETER. THE (OUT) LUER OF THE CATHETERS WAS CLAMPED BEFORE THE VACUUM FROM THE SYRINGE WAS APPLIED TO THE (IN) LUER. ADDITIONALLY, THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373429 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED A LEAK IN THE SOLEX CATHETER (LOT 204764). AN AIR TRAP ALARM WAS DISPLAYED ON THE THERMOGARD XP IVTM SYSTEM. BLOOD WAS OBSERVED IN THE START-UP KIT (SUK) AND THE NACL BOTTLE WAS EMPTY. THE DWELL TIME WAS 6 HOURS. THE CATHETER WAS INSERTED SMOOTHLY INTO THE SUBCLAVIAN SITE ON THE MALE PATIENT ON THE FIRST ATTEMPT, FOR FEVER PREVENTION. APPROXIMATELY 250ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM IS SUSPECTED. THE CATHETER WAS REPLACED TO CONTINUE THERAPY USING THE SAME CONSOLE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078961 ↗
• MalfunctionJul 1, 2025Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT IVTM THERAPY FOR HYPOTHERMIA AFTER OUT-OF-HOSPITAL CARDIAC ARREST (OHCA) UTILIZING THE SOLEX 7 CATHETER (LOT # 204764), WHICH WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR (IJ). AFTER SIX DAYS OF TREATMENT, IT WAS NOTED THE PATIENT'S TEMPERATURE DID NOT REACH THE SET TEMPERATURE. THE PATIENT'S TEMPERATURE WAS 37.9 ° C. THE TARGET TEMPERATURE WAS SET TO 37°. THE CONSOLE WAS SET TO MAX. MODE. THE START-UP KIT (SUK) PINWHEEL WAS NOT SPINNING, BUT THE ROLLER PUMP IN THE THERMOGARD CONSOLE WAS OPERATING. AFTER PAUSING THE CONSOLE AND DISCONNECTING THE CATHETER FROM THE SUK IN AN ATTEMPT TO FLUSH THE CATHETER BALLOONS, THE FLUSH COULD NOT BE PERFORMED SUCCESSFULLY. THERE WERE NO OBVIOUS SIGNS OF KINKS OR ANYTHING NOTICED ON THE CATHETER. THE CATHETER WAS SUBSEQUENTLY REPLACED WITH ANOTHER CATHETER TO CONTINUE THE THERAPY. THE PATIENT IS STILL IN THE ICU. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379326 ↗
• MalfunctionMay 19, 2025Difficult to Advance; Difficult to Advance

  DURING THE INSERTION OF THE SOLEX 7 CATHETER (LOT #205902) TO INITIATE IVTM THERAPY, THE CATHETER COULD NOT BE THREADED OVER THE GUIDEWIRE. THE CUSTOMER TRIED AN ALTERNATIVE GUIDEWIRE WITH THE SAME DIAMETER AS THE ZOLL GUIDEWIRE, BUT THE ISSUE PERSISTED. THEREFORE, THE CUSTOMER SUSPECTS A NARROW POINT IN THE SOLEX CATHETER. THE IVTM THERAPY WAS INITIATED AND CONTINUED USING THE ICY CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045749 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED AN INCIDENT WITH THE SOLEX CATHETER (LOT UNKNOWN). THEY HAD AN UNFORTUNATE DEFECT WHEN DISCONTINUING THE USE OF THE SOLEX CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21646913 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON NOVEMBER 15TH, HYPOTHERMIA TREATMENT WAS INITIATED USING THE THERMOGARD XP SYSTEM WITH A SOLEX 7 CATHETER (LOT #192581) INSERTED INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN. ON THE AFTERNOON OF NOVEMBER 21ST, A LEAK WAS OBSERVED IN THE CATHETER AT THE INSERTION SITE. CONSEQUENTLY, THE PHYSICIAN DISCONTINUED THE TARGETED TEMPERATURE MANAGEMENT (TTM) PROCEDURE AND REMOVED THE CATHETER. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029457 ↗
• MalfunctionNov 8, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE SOLEX 7 CATHETER (LOT #197459) WAS SMOOTHLY PLACED IN THE PATIENT'S LEFT INTERNAL JUGULAR VEIN FOLLOWING ZOLL INSTRUCTIONS FOR USE (IFU). AT THE START OF THE TREATMENT, THE PATIENT'S BODY TEMPERATURE WAS 35.5°C, AND THE TARGET TEMPERATURE WAS SET TO 36°C AT A RATE OF 0.5°C PER HOUR TO WARM THE PATIENT. DURING AN X-RAY CHECK WITHIN AN HOUR OF CATHETER INSERTION, IT WAS NOTICED THAT THE MEDICATION WAS REACHING THE PATIENT INCONSISTENTLY AND FLUID WAS LEAKING FROM THE INSERTION SITE. PER THE CUSTOMER, THE INFUSIONS THROUGH THE CATHETER LUMENS WERE NOT FUNCTIONING PROPERLY. AFTER 28 HOURS, IT WAS DECIDED TO REMOVE THE CATHETER AND SWITCH TO A REGULAR CENTRAL VENOUS CATHETER. THERE WAS NO REPORT OF A CATHETER BALLOON BREACH OR SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645780 ↗
• MalfunctionNov 8, 2024Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED THE FIRST ATTEMPT TO INSERT THE SOLEX CATHETER (LOT UNKNOWN) IN THE LEFT SUBCLAVIAN VEIN OF THE 76-YEAR-OLD, 172 CM, 51KG FEMALE PATIENT WAS UNSUCCESSFUL. THE CATHETER WAS DISPOSED OF BY THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE FIRST FAILED ATTEMPT TO INSERT THE CATHETER. DURING THE SECOND ATTEMPT, A NEW SOLEX CATHETER (LOT: 197459) WAS PLACED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THE INFUSION LUMENS COULD BE FLUSHED WELL BEFORE INSERTION. THE X-RAY CONFIRMED THE CORRECT POSITIONING OF THE CATHETER. AFTER INSERTION AND THE X-RAY CHECK, MEDICATION ADMINISTRATION THROUGH ALL LUMENS WAS VERY IRREGULAR, WITH MEDICATION OCCASIONALLY LEAKING AT THE INSERTION SITE. THE COOLING FUNCTION OF THE CATHETER WAS NOT AFFECTED. THE PROBLEM ONLY AFFECTED THE INFUSION LUMENS AND NOT THE COOLING LUMENS. THE DWELL TIME WAS APPROXIMATELY 12 HOURS. THE CATHETER WAS REMOVED AFTER 24 HOURS, AND IVTM THERAPY WAS STOPPED. THE CATHETER WAS REPLACED BY A REGULAR CENTRAL VENOUS CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637161 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THE FIRST ATTEMPT TO INSERT THE SOLEX CATHETER (LOT UNKNOWN) IN THE LEFT SUBCLAVIAN VEIN OF THE 76-YEAR-OLD, 172 CM, 51KG FEMALE PATIENT WAS UNSUCCESSFUL. THE CATHETER WAS DISPOSED OF BY THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE FIRST FAILED ATTEMPT TO INSERT THE CATHETER. DURING THE SECOND ATTEMPT, A NEW SOLEX CATHETER (LOT 197459) WAS PLACED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THE INFUSION LUMENS COULD BE FLUSHED WELL BEFORE INSERTION. THE X-RAY CONFIRMED THE CORRECT POSITIONING OF THE CATHETER. AFTER INSERTION AND THE X-RAY CHECK, MEDICATION ADMINISTRATION THROUGH ALL LUMENS WAS VERY IRREGULAR, WITH MEDICATION OCCASIONALLY LEAKING AT THE INSERTION SITE. THE COOLING FUNCTION OF THE CATHETER WAS NOT AFFECTED. THE PROBLEM ONLY AFFECTED THE INFUSION LUMENS AND NOT THE COOLING LUMENS. THE DWELL TIME WAS APPROXIMATELY 12 HOURS. THE CATHETER WAS REMOVED AFTER 24 HOURS, AND IVTM THERAPY WAS STOPPED. THE CATHETER WAS REPLACED BY A REGULAR CENTRAL VENOUS CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636692 ↗
• MalfunctionOct 10, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY FOR HYPOTHERMIA AFTER CARDIAC ARREST A SOLEX 7 CATHETER (LOT #172888) WAS PLACED INTO THE RIGHT SUBCLAVIAN VEIN, AND THE CATHETER INSERTION WAS SMOOTH. THE PATIENT TEMPERATURE AT THE START OF IVTM THERAPY WAS 35.4°C, AND THE TARGET TEMPERATURE WAS SET TO 37.8°C. THE DWELL TIME OF THE CATHETER WAS 6 DAYS. DURING THE FEVER MODE, WHEN THE PATIENT'S TEMPERATURE WAS 36.8°C, THE SALINE BAG WAS NOTED EMPTY AND THE THERMOGARD CONSOLE DISPLAYED A MID:09 (AIR TRAP ASSEMBLY) MESSAGE. NO LEAKED FLUID WAS OBSERVED ON THE PATIENT BED, FLOOR, AND THE THERMOGARD CONSOLE. A CATHETER LEAK AND THE INFUSION OF THE 200ML OF SALINE FLUID WERE SUSPECTED. THE PATIENT HAS ALREADY COMPLETED THE REWARMED PHASE AND THE PHYSICIAN DECIDED TO STOP TREATMENT AND THE SOLEX CATHETER WAS REMOVED. PER THE REPORTER, THE MID:09 ERROR WAS CLEARED, AND THE THERMOGARD CONSOLE WAS PLACED BACK FOR CLINICAL USE. THE PATIENT IS WELL, AND STILL IN ICU. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424660 ↗
• MalfunctionSep 20, 2024Insufficient Cooling; Fluid/Blood Leak; Difficult to Flush; Material Integrity Problem; Insufficient Cooling; Fluid/Blood Leak; Difficult to Flush; Material Integrity Problem

  BIOMED REPORTED THAT THE SOLEX CATHETER (LOT UNKNOWN) WAS LEAKING, AND THE PATIENT RECEIVED +500 ML OF NACL IN THE BLOODSTREAM FROM THE COOLING SYSTEM. PER THE CUSTOMER THE SALINE BAG WAS FOUND TO BE EMPTIED. THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN AIR TRAP ALARM. THE CATHETER WAS SMOOTHLY PLACED INTO THE RIGHT INTERNAL JUGULAR VEIN OF A 50-YEAR-OLD 128KG MALE PATIENT ON THE FIRST ATTEMPT BY AN EXPERIENCED INSERTING PRACTITIONER. A LEAK CHECK WAS PERFORMED PER THE IFU. THE DWELL TIME WAS 24 HOURS. IVTM THERAPY WAS ENDED. THE ERROR MESSAGE ON THE CONSOLE WAS CLEARED AND THE CONSOLE IS BACK IN SERVICE. THE CATHETER WAS REPLACED WITH A CENTRAL VEIN CATHETER (CVK). THERE WAS NO IMPACT TO THE PATIENT DUE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274032 ↗
• InjurySep 17, 2024Use of Device Problem; Use of Device Problem

  WHILE ATTEMPTING TO INSERT THE SOLEX 7 CATHETER (LOT #186920) INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE INSERTION SITE WAS WELL DILATED, AND THE GUIDEWIRE ADVANCED SMOOTHLY. HOWEVER, THE CATHETER WAS FOUND TO BE KINKED. CONSEQUENTLY, THE CATHETER WAS NEITHER INSERTED NOR REPLACED. NO INTERVENTION WAS NECESSARY OR PLANNED. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT IS ALIVE WITHOUT ANY REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243031 ↗
• MalfunctionSep 13, 2024Difficult to Remove; Difficult to Remove

  THE SOLEX 7 CATHETER (LOT #198495) WAS UTILIZED IN IVTM THERAPY FOR A BURN PATIENT. THE CUSTOMER REPORTED SIGNIFICANT DIFFICULTY WHILE REMOVING THE CATHETER, NOTING THE PRESENCE OF BLOOD CLOT FRAGMENTS ON THE SERPENTINE BALLOON. THE CUSTOMER REPORTED THEY FOLLOWED ZOLL IFU INSTRUCTIONS TO ACHIEVE A SAFE CATHETER REMOVAL BY DEFLATING THE BALLOON WITH A 20-ML SYRINGE TO REMOVE RESIDUAL SALINE AND ROTATING THE CATHETER DURING EXTRACTION. THE CUSTOMER WAS CONCERNED ABOUT THE APPEARANCE OF THE CATHETER UPON REMOVAL. ALTHOUGH THE SOLEX 7 CATHETER'S SERPENTINE BALLOON REMAINED INTACT, THE RESISTANCE ENCOUNTERED DURING REMOVAL RAISED CONCERNS ABOUT POTENTIAL BLOOD VESSEL INJURY. WHILE THE PATIENT WAS NOT HARMED, THE CUSTOMER EXPRESSED CONCERNS REGARDING THE APPARENT BLOOD CLOTS ON THE CATHETER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215845 ↗
• MalfunctionSep 9, 2024Difficult to Remove; Difficult to Remove

  THE SOLEX 7 CATHETER (LOT #UNKNOWN) WAS UTILIZED IN IVTM THERAPY FOR A BURN PATIENT. THE CUSTOMER REPORTED SIGNIFICANT DIFFICULTY WHILE REMOVING THE CATHETER, NOTING THE PRESENCE OF BLOOD CLOT FRAGMENTS ON THE SERPENTINE BALLOON. THE CUSTOMER REPORTED THEY FOLLOWED ZOLL IFU INSTRUCTIONS TO ACHIEVE A SAFE CATHETER REMOVAL BY DEFLATING THE BALLOON WITH A 20-ML SYRINGE TO REMOVE RESIDUAL SALINE AND ROTATING THE CATHETER DURING EXTRACTION. THE CUSTOMER WAS CONCERNED ABOUT THE APPEARANCE OF THE CATHETER UPON REMOVAL. ALTHOUGH THE SOLEX 7 CATHETER'S SERPENTINE BALLOON REMAINED INTACT, THE RESISTANCE ENCOUNTERED DURING REMOVAL RAISED CONCERNS ABOUT POTENTIAL BLOOD VESSEL INJURY. WHILE THE PATIENT WAS NOT HARMED, THE CUSTOMER EXPRESSED CONCERNS REGARDING THE APPARENT BLOOD CLOTS ON THE CATHETER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174322 ↗