SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause Hep SL-2593Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00849111075305), received between Oct 25, 2016 and Dec 26, 2025 — classified as 2 deaths, 18 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (67 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER NOTED DURING THE MAINTENANCE PHASE, THE VOLUME OF THE SALINE BAG DROPPED ABOUT 100 CC BELOW THE MARKING PLACED BY THE PREVIOUS SHIFT TEAM THAT HAD PLACED THE SOLEX CATHETER (LOT UNKNOWN) AND STARTED TREATMENT. THE CUSTOMER WAS ADVISED TO CHECK THE LUER LOCKS, UNDER THE PATIENT'S BED, AND AROUND THE CONSOLE FOR SIGNS OF LEAKING BUT NO LEAKED SALINE WAS OBSERVED. THEY WERE ADVISED THAT IT APPEARS THERE IS A LEAK IN THE CATHETER. THE CUSTOMER WAS ADVISED TO STOP TREATMENT AND CONTACT THE PROVIDER TO REMOVE THE CATHETER DUE TO THE POSSIBLE LEAK. THE PROVIDER REPLACED THE CATHETER AND SUK TO CONTINUE THERAPY USING THE SAME CONSOLE. NO MALFUNCTION WAS REPORTED FOR THE ORIGINAL SUK. IVTM THERAPY BEGAN ON (B)(6) 2025. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898442 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THE SOLEX CATHETER (LOT UNKNOWN) WAS PLACED IN THE IJ ON 11/9. IT WAS SMOOTHLY INSERTED ON THE FIRST ATTEMPT. ON 11/11/25, THE NURSE NOTED BLOOD IN THE TUBING OF THE START-UP KIT (SUK). THERAPY WAS STOPPED AND THE SOLEX CATHETER WAS REMOVED. PER VISUAL INSPECTION, THE CUSTOMER NOTED THEY SAW A HOLE IN ONE OF THE SOLEX BALLOONS. THE DWELL TIME WAS 2 DAYS. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762047 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE MAINTENANCE PHASE OF THE IVTM THERAPY USING THE SOLEX 7 CATHETER (LOT #UNKNOWN), THE CUSTOMER OBSERVED BLOOD IN THE START-UP KIT (SUK) TUBING AND A DECREASE IN SALINE FROM THE SALINE BAG. THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER SUSPECTS APPROXIMATELY 250 ML OF SALINE WAS INFUSED INTO THE PATIENT'S BLOODSTREAM. THE CATHETER DWELL TIME WAS 12 HOURS. THE CUSTOMER DISCONTINUED THE IVTM THERAPY. 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 23759351 ↗
• InjuryDec 2, 2025Difficult to Remove; Difficult to Remove

  THE SOLEX 7 CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE RIGHT IJ (INTERNAL JUGULAR) TO INITIATE IVTM THERAPY. WHEN ATTEMPTING TO REMOVE THE CATHETER, THE NURSE ENCOUNTERED RESISTANCE. ANOTHER NURSE AND TWO INTENSIVISTS ALSO TRIED TO REMOVE IT AT THE BEDSIDE. A BEDSIDE ULTRASOUND WAS PERFORMED, AND THE PHYSICIAN INITIALLY SUSPECTED A CLOT AROUND THE CATHETER. IR (INTERVENTIONAL RADIOLOGY) WAS CONSULTED FOR REMOVAL AND RECOMMENDED A VASCULAR CONSULTATION. THE HOSPITAL'S CARDIOVASCULAR (CV) SURGEON TOOK THE PATIENT TO THE OPERATING ROOM (OR). THE PATIENT WAS POSITIONED FOR CAROTID SURGERY, AND AFTER A TIMEOUT INCLUDING IDENTIFICATION, LATERALITY, PROCEDURE, PERSONNEL, AND CONSENT, THE PHYSICIAN MADE A 3 CM INCISION OVER THE CATHETER SITE. DISSECTION THROUGH THE STERNOCLEIDOMASTOID MUSCLE WAS PERFORMED, FOLLOWING THE CATHETER. AT THIS POINT, ENOUGH SOFT TISSUE HAD BEEN CLEARED TO REMOVE THE CATHETER. UPON REMOVAL, THE BALLOON WAS FOUND TO BE NO LONGER SMOOTH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23700722 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED A LEAK IN THE SOLEX CATHETER (LOT UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611591 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2025, THE CUSTOMER REPORTED A LEAK IN THE SOLEX CATHETER (LOT UNKNOWN). IN THIS CASE, THE BALLOON REMAINED INTACT, BUT THE LEAK OCCURRED AT THE HUB PROXIMAL TO THE PATIENT. THE ISSUE WAS DISCOVERED WHEN THE CUSTOMER NOTICED THE SALINE BAG WAS EMPTY AND THE BED WAS WET. TROUBLESHOOTING WAS PERFORMED. ALL CONNECTIONS WERE SECURE AND PROPERLY ATTACHED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611415 ↗
• InjuryMar 11, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT'S TEMPERATURE WAS MONITORED AND CONTROLLED USING THE SOLEX 7 CATHETER (LOT #204215), WHICH WAS INSERTED INTO THE PATIENT'S LEFT INTERNAL JUGULAR (IJ). DURING THERAPY, THE 1-LITER SALINE BAG WAS FOUND TO BE EMPTY. UPON FURTHER ASSESSMENT, THE PATIENT'S NECK APPEARED VISIBLY ENLARGED. THE THERAPY WAS HALTED, AND THE SOLEX 7 CATHETER WAS REMOVED FROM THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER, THE INFILTRATION WAS MONITORED, AND IT WAS RESOLVED WITHIN 48 HOURS. NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: Infiltration into Tissue

  MAUDE report 21579539 ↗
• MalfunctionMar 2, 2025Use of Device Problem; Use of Device Problem

  DURING THE REMOVAL OF A SOLEX 7 CATHETER (LOT# UNKNOWN), FOUR DAYS AFTER THE CATHETER PLACEMENT, THE BALLOON APPEARED TO HAVE DAMAGE. THE BEDSIDE NURSE INITIALLY ATTEMPTED REMOVAL BUT ENCOUNTERED RESISTANCE AND SOUGHT ASSISTANCE FROM THE ATTENDING PHYSICIAN. ALTHOUGH THE PHYSICIAN SUCCESSFULLY REMOVED THE CATHETER, THE RESISTANCE WAS GREATER THAN EXPECTED. PER THE REPORTER, THE CATHETER DEFLATION BEFORE THE REMOVAL WAS DONE USING THE RECOMMENDED PROCEDURE. EXAMINATION OF THE SOLEX BALLOON REVEALED A SECTION STRIPPED FROM THE CATHETER SHAFT AND SEVERED FROM THE REST OF THE BALLOON. PER THE REPORTER, THE SOLEX CATHETER WAS THE PATIENT'S ONLY INVASIVE LINE, WITH NO OTHER FOREIGN BODIES PRESENT (E.G., PACEMAKERS, ICDS, IVC FILTERS). THE RESISTANCE AND RESULTING BALLOON DAMAGE APPEARED TO BE CONSISTENT WITH NORMAL VASCULATURE. ADDITIONALLY, THERE WERE NO ISSUES DURING THE INSERTION OF THIS CATHETER, AND COOLING AND WARMING THERAPY PROCEEDED WITHOUT COMPLICATIONS. NO SURGICAL INTERVENTION WAS REQUIRED AND NO ADVERSE EFFECTS ON THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500921 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER CONTACTED ZOLL TECH LINE TO REPORT A HOLE DISCOVERED IN THE DISTAL PORT OF A SOLEX 7 CATHETER (LOT # 199265), WHICH WAS INSERTED IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. THE CALLER STATED THE HOLE WAS FOUND AFTER NOTICING THERE WAS BLOOD COMING OUT OF THE LINE ATTACHED TO THE DISTAL PORT AND THAT THE HOLE WAS VISIBLE. IT IS UNKNOWN HOW LONG AFTER THE TREATMENT BEGAN, THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF AN "AIR TRAP" ALARM. ZOLL TECH LINE WALKED THE CALLER THROUGH THE SAFE REMOVAL OF THE CATHETER. THE CATHETER WAS REPLACED AND TREATMENT CONTINUED. THERE WERE NO ISSUES WITH THE THERMOGARD CONSOLE USED DURING THE EVENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329575 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A CARDIAC ARREST PATIENT USING A SOLEX 7 CATHETER (LOT #201702) AND A THERMOGARD HQ START-UP KIT (SUK) #1 (LOT #204066). FOLLOWING THE SET-UP AND DURING THE INITIATION OF THERAPY, A SALINE LEAK WAS IDENTIFIED IN THE SUK #1 TUBING, WHICH WAS INSERTED INTO THE ROLLER PUMP OF THE THERMOGARD HQ SYSTEM. THE CUSTOMER REPLACED THE SUK #1 BUT OBSERVED A SIMILAR LEAK IN THE SUK #2 (LOT #204066) TUBING AT THE SAME SECTION OF THE TUBING. FOLLOWING THE SECOND REPLACEMENT, THE CUSTOMER NOTED A BLOOD TINGE (INDICATION OF CATHETER LEAK) IN THE SUK #3 (LOT #204066) TUBING. PER THE CUSTOMER, NO BLOOD TINGE WAS OBSERVED IN THE FIRST TWO SUK TUBINGS. THE CUSTOMER PLACED THE THERMOGARD HQ SYSTEM ON STANDBY AFTER THE LEAK WAS NOTED AND BEFORE THE "AIR TRAP WARNING" ALARM. THE CUSTOMER SUSPECTS LESS THAN 200 ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE CATHETER WAS LESS THAN AN HOUR. CONSEQUENTLY, THERAPY WAS DISCONTINUED WITH THE THERMOGARD HQ SYSTEM AND WAS RESUMED USING AN ALTERNATIVE TEMPERATURE MANAGEMENT SYSTEM. NO CONSEQUENCES OR ADVERSE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860386 ↗
• InjuryNov 27, 2024Use of Device Problem; Use of Device Problem

  ON 11/1/24 AT 03:13, A NURSE CONTACTED THE TECHNICAL SUPPORT LINE TO REPORT AN ISSUE WITH THE START-UP KIT (SUK): THE FLOW INDICATOR (RED PINWHEEL) DID NOT SPIN (THOUGH THE ROLLER PUMP WAS ACTIVE) WHILE ATTEMPTING TO COOL A PATIENT IN MAX POWER MODE VIA A SOLEX 7 (LOT # UNKNOWN) CATHETER PLACED IN THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2024. THE PATIENT WAS NOT ACHIEVING THE TARGET TEMPERATURE OF 37°C WITH THE CURRENT PATIENT TEMPERATURE OF 37.8°C. NO LOSS OF LIQUID OR ALARMS WERE OBSERVED. SETTINGS AND SETUP WERE VERIFIED, CONFIRMING THE DEVICE WAS IN RUN MODE AND THE TUBING WAS FREE OF KINKS. THE TECHNICAL SUPPORT TEAM ADVISED TAPPING THE PINWHEEL ON THE SUK GENTLY TO RELEASE ANY AIR, BUT THIS DID NOT RESOLVE THE ISSUE. AFTER PAUSING THERAPY, DISCONNECTING, REPRIMING, AND RECONNECTING THE SUK TUBING, THE SAME PROBLEM PERSISTED. A NEW CONSOLE AND SUK SETUP WERE IMPLEMENTED, BUT THE ISSUE CONTINUED. THE CUSTOMER DISCONNECTED THE SUK FROM THE CATHETER, RECONNECTED IT IN A CLOSED LOOP, AND VERIFIED IT WAS FUNCTIONING AS EXPECTED. AFTER INSPECTING THE SOLEX 7 CATHETER PER THE IFU, THE CUSTOMER ATTEMPTED TO FLUSH THE IN AND OUT LUERS TO CHECK SALINE FLOW; WHILE SALINE DID FLOW, RESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802892 ↗
• InjuryNov 1, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON OCTOBER 9, 2024, A CUSTOMER CONTACTED THE ZOLL TECH LINE TO REPORT A SUSPECTED LEAK IN THE SOLEX 7 CATHETER (LOT #199921), WHICH WAS NOTED ON THURSDAY, (B)(6) 2024. THE RN OBSERVED SWELLING IN THE PATIENT'S LEFT INTERNAL JUGULAR VEIN WHERE THE SOLEX CATHETER WAS INSERTED. THE RN INFORMED THE PROVIDER, WHO THEN DECIDED TO DISCONTINUE THERAPY AND REMOVE THE CATHETER. UPON REMOVING THE CATHETER, PRESSURE WAS HELD TO THE INSERTION SITE TO MITIGATE THE SWELLING. THE INCIDENT OCCURRED DURING THE MAINTENANCE PHASE OF THE HYPOTHERMIA PROTOCOL, APPROXIMATELY 12 HOURS AFTER THE CATHETER HAD BEEN PLACED. THE CUSTOMER REPORTED THAT NO ALARMS WERE TRIGGERED ON THE CONSOLE. ADDITIONALLY, THE CUSTOMER MENTIONED UNCERTAINTY ABOUT WHETHER THE SALINE BAG HAD BEEN REPLACED BUT NOTED THAT 400 ML REMAINED FROM THE ORIGINAL 500 ML BAG. SINCE THE TARGET TEMPERATURE GOAL OF 36°C WAS REACHED, NO FURTHER ALTERNATIVE THERAPY WAS INITIATED AFTER REMOVING THE CATHETER.

  Patient problems: Swelling/ Edema

  MAUDE report 20589513 ↗
• MalfunctionJun 13, 2024Use of Device Problem; Use of Device Problem

  AN IVTM THERAPY WAS INITIATED FOR A PATIENT USING A SOLEX 7 (LOT #UNKNOWN) CATHETER. AT THE END OF THE THERAPY, THE NURSE REPORTED DIFFICULTY REMOVING THE CATHETER. PER THE NURSE, THE CATHETER WAS DEFLATED WITH A SLIP-TIP SYRINGE BEFORE BEING REMOVED, AND THE LUERS WERE LEFT OPEN TO THE AIR. THE CUSTOMER EXPERIENCED DIFFICULTY GETTING CLOSE TO THE DISTAL TIP OF THE CATHETER WHILE REMOVING IT. APPROXIMATELY ONE INCH WAS LEFT IN THE VESSEL WHEN THE CUSTOMER FELT THE RESISTANCE. ZOLL CLINICAL TERRITORY ASSOCIATE ADVISED THE CUSTOMER TO TURN THE CATHETER CLOCKWISE AND GENTLY REMOVE IT. HOWEVER, THE REGISTERED NURSE AND PHYSICIAN ASSISTANT CONTINUED EXPERIENCING RESISTANCE EVEN WHEN TURNING CLOCKWISE. ZOLL CLINICAL TERRITORY ASSOCIATE ADVISED THE CUSTOMER TO REMOVE THE CATHETER UNDER FLUOROSCOPY OR X-RAY. IR PHYSICIAN ASSESSED THE PATIENT AND SUCCESSFULLY REMOVED THE CATHETER AT THE BEDSIDE. NO INTERVENTION WAS TAKEN, NO OCCLUSIONS WERE FOUND, THE PATIENT HAD NO ADVERSE EFFECTS AFTER REMOVAL, AND THE CATHETER INSERTION SITE SHOWED NO ABNORMALITIES POST-REMOVAL. THE DWELL TIME OF THE CATHETER WAS TWO DAYS. PER THE REPORTER, THERE WAS NO OCCLUSION OR INCREASED TORTUOSITY IN THE VEIN. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534156 ↗
• MalfunctionJun 13, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2024 AT 06:45 EST, A NURSE AT (B)(6) REPORTED HER PATIENT WAS ON REWARMING THERAPY VIA THE THERMOGARD XP IVTM SYSTEM AND THERE WAS BLOOD IN THE SALINE BAG, AS WELL AS VOLUME LOST FROM THE SALINE BAG. THE DEVICE WAS PLACED IN STANDBY WHILE THE ZOLL REP. EDUCATED THE NURSE CARING FOR THE PATIENT AND THE CHARGE NURSE THAT THERE IS A SUSPECTED CATHETER LEAK, AND THAT THE LINE NEEDS TO BE DISCONTINUED AND REPLACED. THE FEMALE POST-CARDIAC ARREST PATIENT CAME INTO THE HOSPITAL ON (B)(6), AND THE SOLEX CATHETER (LOT UNKNOWN) WAS PLACED IN THE SUBCLAVIAN IN THE EMERGENCY DEPARTMENT. THEY COOLED THE PATIENT TO 33.0 DEGREES, STARTED REWARMING AT 1AM AND NOW THE PATIENT IS 35.1 DEGREES (AT 0330). THEY CURRENTLY HAD NOREPINEPHRINE RUNNING. THE ZOLL REP. ADVISED THEM TO CONTINUE USING THE LINE AND GAIN ACCESS ANOTHER WAY BEFORE DISCONTINUING. THE CHARGE NURSE TALKED WITH THE PROVIDER ABOUT REPLACING THE LINE IN A TIMELY MANNER. THEY GRABBED A BEAR HUGGER IN THE MEANTIME FOR REWARMING THE PATIENT. IVTM THERAPY WAS NOT CONTINUED. NO ISSUES WERE REPORTED WITH THE CONSOLE. THE CATHETER WAS REMOVED NO LATER THAN (B)(6), BUT IT WAS NOT USED FOR TEMPERATURE CONTROL AFTER THE TECH LINE CALL O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534110 ↗
• MalfunctionJun 7, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT THE SOLEX 7 CATHETER (LOT #197077) WAS INSERTED INTO A PATIENT'S RIGHT INTERNAL JUGULAR VEIN TO PROVIDE IVTM THERAPY. DURING THE REWARMING PHASE OF THE TREATMENT, THE NURSE OBSERVED BLOOD IN THE TUBING. THERE WAS NO "AIR TRAP" ALARM, BUT THE VOLUME OF SALINE SOLUTION IN THE BAG HAD DECREASED. ZOLL IVTM TECH SUPPORT ADVISED THE CUSTOMER TO REMOVE THE CATHETER AS THERE APPEARED TO BE A LEAK IN THE CATHETER'S BALLOON. IT IS UNKNOWN WHETHER THE CATHETER WAS REPLACED TO CONTINUE THE TREATMENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483255 ↗
• MalfunctionMar 17, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, A ZOLL CATHETER (LOT# UNKNOWN) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN. AT THE END OF THE THERAPY, THE BLOOD WAS NOTED IN THE CATHETER TUBING, AND THE CATHETER LEAK WAS SUSPECTED. THE CATHETER WAS REMOVED AS THE PATIENT WAS DONE WITH THE TREATMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PER THE REPORTER, IT IS UNKNOWN WHAT MODEL OF ZOLL CATHETER WAS USED DURING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919226 ↗
• MalfunctionFeb 21, 2024Difficult to Insert; Difficult to Insert

  THE SOLEX 7 CATHETER WAS USED WITH A TGHQ CONSOLE. THE CUSTOMER REPORTED HAVING DIFFICULTY PLACING THE SOLEX 7 CATHETER INTO THE PATIENT'S BODY. PER THE CUSTOMER, THE GUIDEWIRE WAS FLIMSY, AND THE STRUCTURE OF THE CATHETER ALMOST FELT LIKE IT WAS MADE FOR A LEFT-HANDED INSERTION. THE CUSTOMER DISCARDED THE SOLEX KIT AND OPTED TO INSERT A QUATTRO CATHETER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754566 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE NORMOTHERMIA PHASE OF TREATMENT, THE CUSTOMER REPORTED THE SOLEX CATHETER (LOT # 191654) HAD BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING AND THE SALINE BAG WAS OBSERVED EMPTY. THERE APPEARS TO BE A LEAK IN THE BALLOONS OF THE CATHETER. THE NURSE STOPPED THE THERAPY AND DISCONNECTED AND CLAMPED THE CATHETER LINES. THE NURSE WAS ADVISED THAT THE REMOVAL OF THE CATHETER WOULD BE RECOMMENDED. THE EXACT DWELL TIME IS UNKNOWN, BUT THE PATIENT HAD BEEN IN THE LAST STAGE OF THE IVTM TREATMENT AT THE TIME OF THE LEAK. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 18708303 ↗
• MalfunctionDec 2, 2023Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT IVTM THERAPY FOR FEVER MANAGEMENT. THE SOLEX 7 CATHETER (LOT # 184662) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. THE FOLLOWING DAY, THE CUSTOMER OBSERVED THE PINWHEEL OF THE START-UP KIT (SUK) (LOT# UNKNOWN) NOT SPINNING. THE IN AND OUT LUERS OF THE SUK WERE DISCONNECTED FROM THE CATHETER AND RE-CONNECTED TOGETHER FOR TESTING PURPOSES; HOWEVER, THERE WAS NO SUK PINWHEEL ROTATION NOTED. THE USER WAS UNABLE TO FLUSH THE IN AND OUT LUIERS OF THE SOLEX 7 CATHETER WITH THE SYRINGE. THE PATIENT'S HEAD WAS REPOSITIONED, AND THE USER WAS ABLE TO FLUSH THE LINE WITH A SIGNIFICANT EFFORT. ALL INFUSION PORTS OF THE SOLEX 7 CATHETER WERE FLUSHED WAY EASIER THAN IN AND OUT LUIERS. THE CUSTOMER WAS ADVISED TO REMOVE THE CATHETER. THE SOLEX CATHETER WAS REMOVED, AND THE NEW SOLEX CATHETER WAS PLACED AT THE SAME SITE. THE IVTM TREATMENT WAS CONTINUED WITH NO ISSUES. NO ADVERSE EVENT WAS REPORTED. PER THE REPORTER, THE PATIENT'S TREATMENT IS ONGOING WITH NO ISSUES OR CONCERNS REPORTED. PER THE NURSE PRACTITIONER, THE PATIENT HAD BEEN AWAKE, ALERT, AND MOVING BEFORE THE ISSUE OCCURRED. SHE BELIEVES THE OBSERVED ISSUES WERE RELATED TO THE PATIENT'S POSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253258 ↗
• MalfunctionAug 25, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, CUSTOMER REPORTED THAT THE THERMOGARD CONSOLE (SN (B)(6)) GENERATED AN "AIR TRAP" WARNING ALARM AND BLOOD-TINGE WAS NOTICED IN THE SOLEX 7 CATHETER AND START-UP KIT (SUK) (LOT #191220) TUBING. THE 1000ML SALINE BAG WAS NOTED HALF FULL. CUSTOMER SUSPECTED A POSSIBLE SOLEX 7 CATHETER (LOT #178732) LEAK. THE SOLEX 7 CATHETER WAS REMOVED, AND TREATMENT DISCONTINUED. IT WAS NOTED THAT THE CATHETER HAD NO VISIBLE DAMAGE AFTER IT WAS REMOVED FROM THE PATIENT. THE CATHETER INSERTION WAS AT THE PATIENT'S RIGHT SUBCLAVIAN VEIN WITHOUT ANY ISSUE. CATHETER DWELL TIME WAS 48 HOURS. PER REPORTER, A 1000ML SALINE BAG WAS USED RATHER THAN A 500ML SALINE BAG DUE TO LACK OF AVAILABILITY. THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628750 ↗
• MalfunctionJun 9, 2023Difficult to Advance; Difficult to Advance

  DURING THE SOLEX 7 (LOT # 172347) CATHETER PLACEMENT FOR AN IVTM THERAPY, THE CUSTOMER EXPERIENCED DIFFICULTY WHILE ADVANCING THE CATHETER. PER THE NURSING STAFF, THE PHYSICIAN DID NOT USE AN INTRODUCER DURING THE CATHETER PLACEMENT. A SECOND CATHETER WAS SUCCESSFULLY PLACED IN THE SAME LOCATION TO CONTINUE IVTM THERAPY. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096086 ↗
• MalfunctionMay 8, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE PROXIMAL SECURING DEVICE CONTINUES TO DISLODGE OFF THE SOLEX 7 CATHETER, WHICH CAUSES THE CATHETER TO MALPOSITION RESULTING IN LEAKAGE OF INTRAVASCULAR FLUID FROM PROXIMAL OR MEDIAL INFUSION LUERS (AS THE CATHETERS WERE NO LONGER IN THE VESSEL). THE CUSTOMER STATED THAT THE REPORTED ISSUE COULD CAUSE A RISK OF INFECTION AND THE RISK OF INFILTRATION OF VASOACTIVE FLUIDS INTO SQ (SUBCUTANEOUS) SPACE. THE SUTURE TAB AND CLIP PROVIDED IN THE CATHETER KIT ARE NOT TIGHT ENOUGH, ALLOWING THE CATHETER TO SLIP OUT OF THE VESSEL. THE CATHETER IS NOT STAYING IN PLACE WITHIN THE SUTURE TAB AND CLIP. THE CUSTOMER STATED THAT THE REPORTED ISSUE HAD HAPPENED MULTIPLE TIMES. NO ADVERSE REACTIONS TO THE PATIENT WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16889235 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED FOR IVTM THERAPY AFTER EXPERIENCING CARDIAC ARREST ON MARCH 18TH. A SOLEX 7 CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN BY AN ADVANCED PRACTICE PROVIDER (APP). CATHETER INSERTION WAS SMOOTH AND COMPLETED IN ONE ATTEMPT. AFTER PLACING AN ARTERIAL CATHETER FOR MEDICAL PURPOSES, THERAPEUTIC HYPOTHERMIA WAS INITIATED ON MARCH 18TH AT 23:14. THE CATHETER WAS FUNCTIONING WITHOUT ANY ISSUE UNTIL MARCH 20TH AT AROUND 12:30 PM, WHEN THE BEDSIDE NURSE OBSERVED BLOOD IN THE START-UP KIT (SUK) TUBING. AS REPORTED, THE THERMOGARD CONSOLE HAD NOT GENERATED ANY "AIR TRAP" ALARM BEFORE THE ISSUE WAS NOTICED. UPON FURTHER INSPECTION, THE NURSE NOTICED THAT THE 500-ML SALINE BAG HAD RUN DRY, WHICH RAISED CONCERNS ABOUT A POTENTIAL BALLOON RUPTURE. THE BEDSIDE NURSE IMMEDIATELY NOTIFIED THE NURSE PRACTITIONER (NP), WHO REMOVED THE CATHETER FROM THE PATIENT. INFUSION OF ABOUT 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED (200-250 ML OF SALINE IN THE 500-ML SALINE BAG CIRCULATES IN THE CLOSED-LOOP SYSTEM). THE TREATMENT HAD BEEN COMPLETED, AND THE PATIENT WAS BEING MAINTAINED ON THE SYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748044 ↗
• MalfunctionMar 24, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT UNDERWENT IVTM THERAPY FOR FEVER MANAGEMENT. THE SOLEX 7 CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN IN A SINGLE INSERTION ATTEMPT. THERE WAS NO ARTERIAL CATHETER PLACED FOR MEDICAL REASONS. SHORTLY AFTER STARTING THE TREATMENT, THE CUSTOMER NOTICED A DECREASE IN THE SALINE BAG, EXCEPT FOR THE 200-250 ML CIRCULATING IN THE TUBING. THE CUSTOMER NOTICED THIS ISSUE BEFORE THE THERMOGARD SYSTEM DISPLAY AN "AIR TRAP" ALARM. THE CUSTOMER OBSERVED SALINE ON THE PATIENT'S BED, AND THERE WAS NO BLOOD TINGE IN THE SUK TUBING. THE CUSTOMER SUSPECTED THAT THE ISSUE WAS RELATED TO THE SUK LUERS, SO, THEY REPLACED THE START-UP KIT (SUK) (LOT # UNKNOWN) ALONG WITH THE SALINE BAG. HOWEVER, THE PROBLEM WAS NOT RESOLVED, AND SALINE STARTED TO DECREASE AGAIN IN THE SALINE BAG. THE CUSTOMER CONTACTED ZOLL TECH LINE SUPPORT AND REPORTED EXPERIENCING A POTENTIAL DEFECT IN THE CATHETER LUMEN, CAUSING A SALINE LEAK. THE CUSTOMER DID NOT SUSPECT ANY SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM BUT WAS CONCERNED ABOUT A POTENTIAL ISSUE WITH THE CATHETER. THE ZOLL CLINICAL FIELD PERSONNEL ADVISED THE CUSTOMER TO REPLACE THE CATHETER AT THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607918 ↗
• MalfunctionMar 2, 2023Material Integrity Problem; Material Integrity Problem

  AFTER 6 DAYS OF IVTM THERAPY UTILIZING THE SOLEX 7 CATHETER (LOT# UNKNOWN), THE 500ML SALINE BAG WAS OBSERVED EMPTY (ABOUT 250ML OF SALINE HAD BEEN INFUSED). THE PHYSICIAN ELECTED TO REMOVE THE CATHETER AND FEVER MANAGEMENT THERAPY WAS NOT RESUMED AS THE PATIENT REACHED THE TARGET TEMPERATURE. UPON REMOVAL OF THE CATHETER, IT WAS REPORTED THAT THERE WAS A LEAK OBSERVED IN THE BALLOON. PER THE REPORTER, THE CATHETER WAS SMOOTHLY INSERTED IN THE LEFT INTERNAL JUGULAR VEIN ON THE FIRST ATTEMPT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465429 ↗