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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Zoll has not received the solex catheter in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

• 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
• MDR Report Key: 23898442
• Report Number: 3010617000-2025-00891
• Device Sequence Number: 10388888
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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 Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown