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

Model Number	IC-3893AE
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	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent targeted temperature management (ttm) following cardiopulmonary resuscitation (cpr).The icy catheter (lot # unknown) was smoothly inserted into the patient's femoral vein on the first attempt.No adjunctive temperature management or relative procedures were performed on the patient prior to the ivtm therapy.The patient's initial temperature was not reported.The target temperature was set to 34°c with the rate set to maximum.After 70 hours of therapy, the thermogard system generated an "air trap" alarm.The pump rotor stopped, and the console entered standby mode.The 500 ml saline bag was found empty, and the patient's temperature at the time the issue occurred was 36.5°c.No fluid was detected on the thermogard console, the patient's bed, or the floor.It was suspected that 200 ml of saline solution may have infused into the patient's bloodstream.No malfunction was reported on the thermogard console used during the event.The catheter was subsequently removed.No additional information was provided, and no patient injury was reported.
Additional Manufacturer Narrative
Zoll did not receive the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)
• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24136438
• Report Number: 3010617000-2026-00038
• Device Sequence Number: 5407169
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• 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): 01/21/2026

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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• 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: 12/31/2025
• Initial Report FDA Received Date: 01/21/2026
• 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