ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) IC-3893Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00849111075237), received between Dec 12, 2016 and Jul 14, 2025 — classified as 4 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THREE HOURS AFTER THE IVTM THERAPY BEGAN, THE NURSE OBSERVED A REDUCTION IN THE SALINE LEVEL IN THE IV BAG. UPON EVALUATION, THE PHYSICIAN IDENTIFIED THE ICY CATHETER (LOT # UNKNOWN) AS THE SOURCE OF THE LEAK AND THE REASON FOR THE 50 ML OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE CATHETER WAS SUBSEQUENTLY REPLACED TO ALLOW THE THERAPY TO CONTINUE WITHOUT CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503252 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED AN ISSUE YESTERDAY DURING IVTM THERAPY USING THE ICY CATHETER (LOT 201524). THE SALINE BAG WENT HALF EMPTY. NO BLOOD WAS NOTED IN THE CIRCUIT OR THE SALINE BAG. THERE WAS NO OBSERVABLE LEAK OUTSIDE THE PATIENT. THE CATHETER WAS DISCONNECTED, AND THE MD WAS NOTIFIED. THE PATIENT WAS COMPLETED WITH TTM BUT THE FEMORAL LINE WAS BEING USED FOR IV ACCESS. THE PATIENT WAS PERSISTENTLY HYPERTHERMIC, AS HE WAS FEBRILE, SO THE NURSE WAS GIVEN THE OKAY TO USE THE ICY CATHETER FOR TEMPERATURE MANAGEMENT. THE PATIENT WAS RECONNECTED TO THE CONSOLE AND THE DECREASE IN VOLUME OF THE SALINE BAG WAS NOTICED ABOUT HALF AN HOUR LATER. THE CATHETER WAS REMOVED, AND A COOLING BLANKET WAS USED INSTEAD. THE CATHETER WAS PLACED ON (B)(6) 2025 AT 0105 WITHOUT ISSUES DURING INSERTION. IT WAS REMOVED ON (B)(6) 2025 AT 1705. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342742 ↗
• MalfunctionJun 19, 2025Difficult to Advance; Difficult to Advance

  THE ADVANCED PRACTICE PROVIDER REPORTED DIFFICULTY ADVANCING THE ICY CATHETER (LOT #196374) OVER THE GUIDEWIRE INTO THE PATIENT'S FEMORAL VEIN. THE CUSTOMER REPORTED THAT AFTER PLACING THE GUIDEWIRE IN THE VESSEL, THEY ENCOUNTERED SIGNIFICANT RESISTANCE WHILE ATTEMPTING TO ADVANCE THE CATHETER. THE CUSTOMER STATED THAT THEY DIDN'T FEEL COMFORTABLE ADVANCING THE CATHETER DUE TO CONCERNS ABOUT NOT BEING ABLE TO REMOVE THE GUIDEWIRE. THEY MANAGED TO GET THE GUIDEWIRE TO COME OFF THE CATHETER'S END, BUT WITH A LOT OF RESISTANCE. THE CUSTOMER RETRIEVED A NEW ICY KIT AND SUCCESSFULLY COMPLETED THE INSERTION. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293879 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE MAINTENANCE PHASE OF THE IVTM THERAPY, THE NURSE NOTICED THAT THE SALINE LINE WAS PINK-TINGED. THE IVTM THERAPY WAS STOPPED, NOTIFIED THE PHYSICIAN, AND THE FIRST ICY CATHETER (LOT #202542) WAS REPLACED WITH THE SECOND ICY CATHETER (LOT #202542). DURING THE SECOND ICY CATHETER USE, THE SALINE BAG WAS NOTED TO BE DEPLETING, AND NO BLOOD TINGE WAS NOTED. THE CATHETER WAS REMOVED, AND COOLING PADS WERE USED TO CONTINUE THE THERAPY. THE NURSE SUSPECTS APPROXIMATELY 250CC OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE FIRST ICY CATHETER WAS 8 HOURS, AND THE SECOND ICY CATHETER WAS 6 HOURS. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203602 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE MAINTENANCE PHASE OF THE IVTM THERAPY, THE NURSE NOTICED THAT THE SALINE LINE WAS PINK-TINGED. THE IVTM THERAPY WAS STOPPED, NOTIFIED THE PHYSICIAN, AND THE FIRST ICY CATHETER (LOT # 202542) WAS REPLACED WITH THE SECOND ICY CATHETER (LOT # 202542). DURING THE SECOND ICY CATHETER USE, THE SALINE BAG WAS NOTED TO BE DEPLETING, AND NO BLOOD TINGE WAS NOTED. THE CATHETER WAS REMOVED, AND COOLING PADS WERE USED TO CONTINUE THE THERAPY. THE NURSE SUSPECTS APPROXIMATELY 250CC OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE FIRST ICY CATHETER WAS 8 HOURS, AND THE SECOND ICY CATHETER WAS 6 HOURS. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203601 ↗
• MalfunctionSep 11, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ONCE THE CUSTOMER CONNECTED THE ICY CATHETER (LOT 193912) WITH THE THERMOGARD XP IVTM SYSTEM, THE NURSES FOUND SALINE REDUCING IN THE BAG. UPON FOLLOW UP, IT WAS REPORTED DURING THE MAINTENANCE PHASE OF IVTM THERAPY, THE NIGHT SHIFT NURSE FOUND THE SALINE BAG WAS ALMOST EMPTY. SHE CHECKED ALL AROUND THE CONSOLE AND BED, AND NO SALINE LEAK WAS OBSERVED. SHE REPORTED THE ISSUE TO THE PHYSICIAN ON DUTY. WHEN THEY REMOVED THE CATHETER TO TEST IT OUTSIDE OF THE PATIENT'S BODY, THEY FOUND A LEAK ON THE BALLOON OF THE CATHETER. THE CATHETER AND SALINE BAG WERE REPLACED, AND TREATMENT WAS CONTINUED USING THE SAME CONSOLE. THE DWELL TIME WAS 12 HOURS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196030 ↗
• InjuryAug 22, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A NURSE IN THE ICU CONTACTED ZOLL TO REPORT THAT THE THERMOGARD XP IVTM SYSTEM WAS REPEATEDLY TRIGGERING AIR TRAP ALARMS, INDICATING AIR ACCUMULATION IN THE AIR TRAP CHAMBER OF THE START-UP KIT (SUK). THE ICY CATHETER (LOT #193912) HAD BEEN SMOOTHLY PLACED IN THE PATIENT'S LEFT FEMORAL VEIN WITHOUT ANY OTHER LINES AT THE SAME SITE. THE ZOLL TECHNICAL SUPPORT INSTRUCTED THE NURSE TO CHECK THE SUK CONNECTIONS AND VERIFY ITS CORRECT INSTALLATION. THERE WAS NO EVIDENCE OF SALINE LEAKAGE AROUND THE THERMOGARD CONSOLE OR NEAR THE PATIENT. THE NURSE MENTIONED THAT THE SALINE BAG HAD BEEN DEPLETED ONCE AND SUBSEQUENTLY REPLACED. THE TECHNICAL SUPPORT EMPHASIZED THAT THE SALINE BAG SHOULD NOT BE REPLACED IN THE FUTURE; INSTEAD, ZOLL SHOULD BE CONTACTED IF IT RUNS OUT. THE NURSE WAS INFORMED OF A SUSPECTED LEAK IN THE CATHETER BALLOON AND WAS ADVISED TO HAVE A HEALTHCARE PROVIDER REMOVE THE CATHETER AND CONSIDER INSERTING A NEW ONE. THE PHYSICIAN REMOVED AND REPLACED THE SUSPECTED CATHETER. AFTER THE CATHETER WAS REPLACED, THE AIR TRAP ALARM WAS CLEARED. THE NURSE STATED THAT THE PATIENT HAD DEVELOPED LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT). THE REPORTING NURSE ADDED THAT SCANS WERE DONE

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 20032887 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE COOLING PHASE OF THE IVTM THERAPY USING AN ICY CATHETER (LOT #190479), THE CUSTOMER NOTICED BLOOD IN THE START-UP KIT (SUK) TUBING, AND THE SALINE BAG WAS NOTED TO BE EMPTIED. THE DWELL TIME OF THE CATHETER WAS 5 HOURS. THE CATHETER WAS REPLACED TO CONTINUE THE THERAPY USING THE SAME THERMOGARD XP IVTM SYSTEM. NO CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813399 ↗
• MalfunctionSep 1, 2023Material Integrity Problem; Material Integrity Problem

  ZOLL RECEIVED MEDWATCH REPORT #(B)(4) ON (B)(6) 2023 FOR THE EVENT REPORTED BELOW: THE ICY CATHETER (LOT # UNKNOWN) WAS UTILIZED IN IVTM THERAPY FOR A 44-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN. DURING CONTRAST ADMINISTRATION, A HOLE FORMED IN THE DISTAL LUMEN OF THE CATHETER. THE CUSTOMER REPORTED DEVICE FAILED BUT DID NOT PROVIDE FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

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

  MAUDE report 17671224 ↗
• MalfunctionMay 8, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A 68-YEAR-OLD MALE POST-CARDIAC ARREST PATIENT (WEIGHT: 109 KG). AN ICY CATHETER (LOT #184223) WAS PLACED INTO THE RIGHT FEMORAL VEIN WITH NO EVIDENT COMPLICATIONS PER THE PHYSICIAN. AFTER 2 HOURS OF THERAPY, THE HOSPITAL STAFF NOTICED THE RETURNING NS (NORMAL SALINE) WAS YELLOW IN THE START-UP KIT (SUK) (LOT #185857) TUBING. THERE WAS NO SALINE LOSS NOTED FROM THE SALINE BAG. ZOLL CLINICAL FIELD TRAINER ADVISED THE CUSTOMER OF A POSSIBLE CATHETER BALLOON LEAK AND RECOMMENDED PLACING THE THERMOGARD XP IVTM SYSTEM IN STANDBY MODE TO REPLACE THE CATHETER. THE CUSTOMER NOTIFIED THE PHYSICIAN TO REPLACE THE CATHETER. THE CATHETER AND THE SALINE BAG WERE REPLACED TO CONTINUE AND COMPLETE THE IVTM THERAPY. THE DWELL TIME OF THE CATHETER AT THE TIME OF REMOVAL WAS 5 HOURS. THE PATIENT IS RESPONSIVE, AND ALL VITAL SIGNS ARE STABLE. NO ADVERSE EVENTS OR RHYTHM ANOMALIES WERE WITNESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888618 ↗
• InjurySep 6, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THE PHYSICIAN REPORTED THAT THE RESIDENT'S INITIAL ATTEMPTS AT VENIPUNCTURE TO PLACE THE ICY CATHETER INTO THE RIGHT FEMORAL VEIN WERE UNSUCCESSFUL. THE PHYSICIAN TOOK OVER AND INITIATED THE CATHETER PLACEMENT PROCEDURE USING THE FIRST ICY CATHETER. THE PHYSICIAN HAS AN EXTENSIVE EXPERIENCE SINCE 2007 IN INTRAVASCULAR CATHETER PLACEMENT. THE LEFT INGUINAL REGION WAS THEN PREPPED AND DRAPED, AND THE PHYSICIAN COULD ACCESS THE LEFT FEMORAL VEIN IN A SINGLE ATTEMPT BUT COULD NOT ADVANCE THE GUIDEWIRE MORE THAN HALF ITS LENGTH. THE PHYSICIAN WAS ABLE TO PERFORM DILATION OVER THE GUIDEWIRE BUT COULD NOT ADVANCE THE CATHETER BY MORE THAN 50% OF ITS LENGTH. THE PHYSICIAN REMOVED THE GUIDEWIRE AND TRIED TO RE-THREAD IT, BUT THE GUIDEWIRE GOT STUCK WITHIN THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE FIRST CATHETER AND GUIDEWIRE OUT OF THE VESSEL WHILE APPLYING PRESSURE TO MINIMIZE BLEEDING. THE PHYSICIAN STATED THAT THE BLEEDING WAS SIGNIFICANT AS THE TRACT HAD BEEN DILATED OVER THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND CATHETER ON THE SAME VESSEL. THE PHYSICIAN REASSESSED THE VESSEL USING THE FINDER NEEDLE AND WAS ABLE TO PASS A SECOND GUIDEWI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15366801 ↗
• InjurySep 6, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THE PHYSICIAN REPORTED THAT THE RESIDENT'S INITIAL ATTEMPTS AT VENIPUNCTURE TO PLACE THE ICY CATHETER INTO THE RIGHT FEMORAL VEIN WERE UNSUCCESSFUL. THE PHYSICIAN TOOK OVER AND INITIATED THE CATHETER PLACEMENT PROCEDURE USING THE FIRST ICY CATHETER. THE PHYSICIAN HAS AN EXTENSIVE EXPERIENCE SINCE 2007 IN INTRAVASCULAR CATHETER PLACEMENT. THE LEFT INGUINAL REGION WAS THEN PREPPED AND DRAPED, AND THE PHYSICIAN COULD ACCESS THE LEFT FEMORAL VEIN IN A SINGLE ATTEMPT BUT COULD NOT ADVANCE THE GUIDEWIRE MORE THAN HALF ITS LENGTH. THE PHYSICIAN WAS ABLE TO PERFORM DILATION OVER THE GUIDEWIRE BUT COULD NOT ADVANCE THE CATHETER BY MORE THAN 50% OF ITS LENGTH. THE PHYSICIAN REMOVED THE GUIDEWIRE AND TRIED TO RE-THREAD IT, BUT THE GUIDEWIRE GOT STUCK WITHIN THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE FIRST CATHETER AND GUIDEWIRE OUT OF THE VESSEL WHILE APPLYING PRESSURE TO MINIMIZE BLEEDING. THE PHYSICIAN STATED THAT THE BLEEDING WAS SIGNIFICANT AS THE TRACT HAD BEEN DILATED OVER THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND CATHETER ON THE SAME VESSEL. THE PHYSICIAN REASSESSED THE VESSEL USING THE FINDER NEEDLE AND WAS ABLE TO PASS A SECOND GUIDEWI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15366607 ↗
• InjurySep 6, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THE PHYSICIAN REPORTED THAT THE RESIDENT'S INITIAL ATTEMPTS AT VENIPUNCTURE TO PLACE THE ICY CATHETER INTO THE RIGHT FEMORAL VEIN WERE UNSUCCESSFUL. THE PHYSICIAN TOOK OVER AND INITIATED THE CATHETER PLACEMENT PROCEDURE USING THE FIRST ICY CATHETER. THE PHYSICIAN HAS AN EXTENSIVE EXPERIENCE SINCE 2007 IN INTRAVASCULAR CATHETER PLACEMENT. THE LEFT INGUINAL REGION WAS THEN PREPPED AND DRAPED, AND THE PHYSICIAN COULD ACCESS THE LEFT FEMORAL VEIN IN A SINGLE ATTEMPT BUT COULD NOT ADVANCE THE GUIDEWIRE MORE THAN HALF ITS LENGTH. THE PHYSICIAN WAS ABLE TO PERFORM DILATION OVER THE GUIDEWIRE BUT COULD NOT ADVANCE THE CATHETER BY MORE THAN 50% OF ITS LENGTH. THE PHYSICIAN REMOVED THE GUIDEWIRE AND TRIED TO RE-THREAD IT, BUT THE GUIDEWIRE GOT STUCK WITHIN THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE FIRST CATHETER AND GUIDEWIRE OUT OF THE VESSEL WHILE APPLYING PRESSURE TO MINIMIZE BLEEDING. THE PHYSICIAN STATED THAT THE BLEEDING WAS SIGNIFICANT AS THE TRACT HAD BEEN DILATED OVER THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND CATHETER ON THE SAME VESSEL. THE PHYSICIAN REASSESSED THE VESSEL USING THE FINDER NEEDLE AND WAS ABLE TO PASS A SECOND GUIDEWI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15366603 ↗
• MalfunctionAug 8, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE ICY CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE RIGHT FEMORAL VEIN BY THE TRAUMA RESIDENT. THE POST-ARREST PATIENT WAS IN THE NORMOTHERMIA PHASE WHEN THE AIR TRAP MESSAGED ALARMED. THERE WERE NO TRACES OF FLUID OBSERVED AROUND THE START-UP KIT (SUK) TUBING, THE FLOOR, OR THE BED. THE SUK AIR TRAP AND THE HOLDER WERE DRY. THE USER OBSERVED THE 1000ML SALINE BAG TO BE ALMOST EMPTY. THE CONSOLE WAS PAUSED FOR TROUBLESHOOTING THE LEAK. THE CUSTOMER WAS INSTRUCTED TO TEST THE CATHETER FOR THE LEAK. THE CATHETER WAS TESTED WITH THE SYRINGE WITH STERILE SALINE AND THE PRESENCE OF A BLOOD TINGE WAS NOTED IN THE CATHETER IN LUER TUBING. A CATHETER LEAK AND THE INFUSION OF 500ML OF SALINE FLUID WERE SUSPECTED. THE ICY CATHETER WAS NOT REPLACED AS THE PATIENT WAS AT THE END OF THE TREATMENT. PER THE REPORTER, THE CONSOLE IS FUNCTIONAL AND READY FOR CLINICAL USE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181711 ↗
• MalfunctionFeb 26, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE START-UP KIT (SUK) (LOT #172206) WAS CONNECTED TO THE THERMOGARD XP IVTM SYSTEM, AND PRIMING WAS PERFORMED TO INITIATE THE IVTM THERAPY FOR A (B)(6)-YEAR-OLD FEMALE PATIENT (WEIGHT - (B)(6) LBS.). AN ICY CATHETER (LOT #UNKNOWN) WAS USED FOR THE IVTM THERAPY. AFTER AN UNKNOWN PERIOD, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) GENERATED AN AIR TRAP ALARM, AND MANY AIR BUBBLES WERE NOTED IN THE SUK AIR TRAP. THE USER OBSERVED AN EMPTY SALINE BAG AND BLOOD TINGE ON THE SUK TUBING, INDICATING A POTENTIAL CATHETER LEAK. THE CUSTOMER DISCARDED THE CATHETER AND THE SUK. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. FOR THE ABOVE-REPORTED EVENT, ZOLL RECEIVED MEDWATCH REPORT # (B)(4) ON (B)(6) 2022. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00241 FOR THE THERMOGARD XP IVTM SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13609184 ↗
• MalfunctionNov 29, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2021, ZOLL RECEIVED A MEDWATCH REPORT # MW5103253: INTRAVASCULAR BALLOON ON COOLING SYSTEM RUPTURED. THE PATIENT RECEIVED 500CC OF NS INTENDED TO CYCLE THROUGH THE BALLOON AND COOL THE PATIENT, NOT BE INFUSED INTO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 12888659 ↗
• MalfunctionNov 23, 2021Use of Device Problem; Use of Device Problem

  BASED ON MEDWATCH REPORT #MW5104540, PROXIMAL BALLOON RUPTURE ON ZOLL ICY CATHETER (LOT #157709) WHILE PLACED IN THE PATIENT'S FEMORAL VEIN. ZOLL STILL IN PROGRESS IN COLLECTING ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 12862512 ↗
• MalfunctionAug 6, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT DURING IVTM THERAPY THE ICY CATHETER (LOT # UNKNOWN) WAS PLACED IN THE PATIENT'S VEIN. THE CATHETER LOCATION WAS NOT SPECIFIED BY THE REPORTER. A CATHETER LEAK WAS SUSPECTED. THE PATIENT TREATMENT WAS STOPPED AFTER REMOVING THE CATHETER, HOWEVER, THE SPECIFICS OF THE ALTERNATIVE THERAPY WERE NOT DISCLOSED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292040 ↗
• MalfunctionOct 6, 2020Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  AT AN UNSPECIFIED TIME, DURING IVTM TREATMENT, THE USER OBSERVED THAT THE PATIENT WAS NOT COOLING. IT WAS OBSERVED THAT THE TEMPERATURE OF THE PATIENT WAS 35.7 C, AND THE CONSOLE WAS SET TO 33 C. THE USER OBSERVED THAT THE PINWHEEL WAS NOT TURNING. THE USER FLUSHED THE IN PORT LUER OF THE ICY CATHETER (LOT# 141208) THAT WAS PLACED IN THE RIGHT FEMORAL VEIN OF THE PATIENT WITH 5 ML. OF SALINE SOLUTION, HOWEVER, THE SALINE WAS UNABLE TO PASS THROUGH. IN ADDITION, X-RAY CONFIRMED PROPER PLACEMENT OF THE CATHETER. IT WAS DETERMINED THAT THE CATHETER DID NOT HAVE SALINE FLOW. THE SUK WAS TESTED IN CLOSED CIRCUIT, AND THE IVTM SYSTEM WAS PLACED IN RUN MODE. THE PUMP WAS ROTATING, AND THE PINWHEEL WAS SPINNING WITHOUT ANY ISSUE. FOLLOWING THIS, THE CATHETER WAS CAPPED, AND A NEW ICY CATHETER WAS PLACED IN THE LEFT FEMORAL VEIN TO CONTINUE THE PATIENT TREATMENT USING THE SAME CONSOLE. NO DEVICE MALFUNCTION WAS REPORTED ON THE IVTM SYSTEM, AND THE SUK. NO CONSEQUENCES, OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10639566 ↗
• MalfunctionMay 15, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING REWARMING PHASE OF IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AN AIR TRAP ALARM AND USER OBSERVED THE SALINE BAG WAS LOW. THE USER DID NOT OBSERVED ANY FLUIDS ON THE FLOOR ON THE BED. SUSPECTING A POSSIBLE BALLOON LEAK. THE USER WAS ABLE TO CLEAR THE AIR TRAP ALARM. FOLLOWING THIS, IVTM THERAPY WAS DISCONTINUED AND LET THE PATIENT WARM PASSIVELY. USER WILL NOT RETURN THE ICY CATHETER DUE TO PATIENT WAS POSITIVE FOR COVID-19. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063897 ↗
• MalfunctionSep 6, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO TAKING THE PATIENT FOR A CT SCAN, THE COOLGARD SYSTEM APPEARED TO BE FUNCTIONING PROPERLY. ONCE THE PATIENT RETURNED, THE COOLGARD SYSTEM WAS RECONNECTED AND TURNED ON. THE SALINE BAG APPEARED TO RUN EMPTY, CUSTOMER REPLACED THE SALINE BAG. HOWEVER, THE COOLGARD SYSTEM DISPLAYED 'AIRTRAP ERROR MESSAGE', THE AIR TRAP WAS EMPTY. CUSTOMER DISCONNECTED AND RE-PRIME THE COOLGARD SYSTEM; HOWEVER, CUSTOMER COULD NOT GET ALL THE AIR OUT OF THE TUBING. CUSTOMER REPLACED THE START-UP KIT, BUT THE SECOND SALINE ALMOST RAN DRY AGAIN. CUSTOMER SUSPECTED THERE WAS A CATHETER LEAK. THE CATHETER WAS REPLACED AND THE PATIENT CONTINUE COOLGARD SYSTEM TREATMENT WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972866 ↗
• MalfunctionApr 2, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING PATIENT THERAPY WITH THE THERMOGARD TGXP, IT WAS OBSERVED TWO BAGS OF SALINE HAD EMPTIED. THE PATIENT WAS INSERTED WITH AN ICY CATHETER THROUGH THE FEMORAL. AFTER INSPECTION, THE USER DID NOT OBSERVE ANY LEAK NEAR THE CONSOLE OR AROUND THE PATIENT. NO ALARM WAS NOTED ON THE CONSOLE. THE CATHETER LEAK WAS SUSPECTED. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476433 ↗
• MalfunctionJan 31, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, ZOLL RECEIVED A MEDWATCH REPORT MW5082215: "HYPOTHERMIA CATHETER FAILED DURING USE - NS FLUID LEVEL NOTED TO BE DECREASING." BASED ON THE FOLLOW-UP INFORMATION, THE PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. THE ICY CATHETER WAS INSERTED ON (B)(6) 2018 AT (B)(6) PM WITHOUT ISSUE IN THE RIGHT FEMORAL VEIN. FOLLOWING DAY, THE SALINE BAG WAS NOTED LOW IN VOLUME. NO LEAK WAS OBSERVED AT THE SITE AND THE CATHETER LEAK WAS SUSPECTED. THE CATHETER WAS REPLACED ON (B)(6) 2018 AT (B)(6) AM TO CONTINUE WITH THERAPY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8295046 ↗
• MalfunctionJan 31, 2019Use of Device Problem; Use of Device Problem

  PER MEDWATCH REPORT #MW5082127, CUSTOMER REPORTED THAT THE FIRST ICY CATHETER PLACED WAS DEFECTIVE WITH A RUPTURE BALLOON AND HAD TO BE REPLACED OVER A GUIDEWIRE. UNCLEAR IF FRAGMENTS OF THE BALLOON WERE RETAINED". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293503 ↗
• MalfunctionDec 11, 2018Defective Component

  PER PHYSICIAN'S NOTE: "THE FIRST ICY CATHETER PLACED WAS DEFECTIVE WITH A BLOWN BALLOON AND HAD TO BE REPLACED OVER A WIRE. UNCLEAR IF FRAGMENTS OF THE BALLOON WERE RETAINED." CATHETER WAS SAVED AND REPORTED TO THE MFR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155091 ↗