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	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported complaint of a leak in the solex catheter (lot 204764) was confirmed during functional testing.A pinhole leak was observed in the middle of serpentine balloon during the functional in/out lumen test.The probable root cause of the pinhole leak was a latent material defect.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Blood residue was observed in the serpentine balloon and in the luered tubings.Functional testing of the returned catheter was performed.All infusion ports and lumen were flushed without resistance.During the in/out lumen test, a pinhole leak was observed in the middle of serpentine balloon, thus, confirming the reported complaint.Pressurized functional testing could not be performed due to the pinhole leak discovered during the in/out lumen test.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints reported for the solex catheter with lot number 204764.

• 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
• MDR Report Key: 23078961
• Report Number: 3010617000-2025-00640
• Device Sequence Number: 4786137
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 08/05/2026
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 204764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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 Sex: Male