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

Model Number	SL-2593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the solex 7 catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information in a2 (age), a3a (sex), a4 (weight), a5 (race), b5 (describe event or problem), d4 (lot #, expiration date), h4 (device manufacture date) and h10 (related report numbers).The customer reported complaint of a catheter leak was confirmed during the functional testing of the returned solex 7 catheter (lot #199921).A pinhole leak was observed at the middle of the serpentine balloon during the functional in/out lumen test.The probable root cause of the pinhole leak was a latent material defect.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the in/out lumen test, a pinhole leak was observed at the middle of the serpentine balloon, confirming the reported complaint.Pressurized functional testing could not be performed due to the pinhole leak discovered during the in/out lumen test.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for investigation related to the reported complaint, and there was no similar complaint reported for solex 7 catheter with lot #199921.
Event or Problem Description
During the maintenance phase of the ivtm therapy using the solex 7 catheter (lot # 199921), 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.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER PRIMUM KIT CUSTOM LUER APPLAUSE HEP
• 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 ; 4084192347
• MDR Report Key: 23759351
• Report Number: 3010617000-2025-00852
• Device Sequence Number: 21352111
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 10/31/2025
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 199921
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: White