MAUDE Adverse Event Report: ZOLL CIRCULATION, INC SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	SL-2593AE
Medical Device Problem Codes	Insufficient Cooling (1130); Fluid/Blood Leak (1250); Difficult to Flush (1251); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the catheter in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
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.
Additional Manufacturer Narrative
B5 (describe event or problem) and d4 (additional device information) were updated with based on addtional information from customer.H6 (adverse event problem) (medical device problem code (a)) was corrected.The reported complaint that the solex catheter (lot 197459) was leaking was confirmed during functional testing.A water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Visual inspection of the returned catheter was performed.No physical damage was observed on the catheter.Blood residue was observed on the balloons.Functional testing of the returned catheter was performed.All the infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi, no leak was observed from the catheter balloons.However, a water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test, confirming the reported complaint.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the solex catheter with lot number 197459.
Event or Problem Description
Biomed reported that the solex catheter (lot 197459) was leaking, and the patient received +500 ml of nacl in the bloodstream from the cooling system.Per the customer the 500 ml 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.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192947
• MDR Report Key: 20274032
• Report Number: 3010617000-2024-00780
• Device Sequence Number: 7314996
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 197459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 128 KG