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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The solex 7 catheter (lot #197459) was smoothly placed in the patient's left internal jugular vein following zoll instructions for use (ifu).At the start of the treatment, the patient's body temperature was 35.5°c, and the target temperature was set to 36°c at a rate of 0.5°c per hour to warm the patient.During an x-ray check within an hour of catheter insertion, it was noticed that the medication was reaching the patient inconsistently and fluid was leaking from the insertion site.Per the customer, the infusions through the catheter lumens were not functioning properly.After 28 hours, it was decided to remove the catheter and switch to a regular central venous catheter.There was no report of a catheter balloon breach or saline infusion into the patient's bloodstream.No consequences or impacts on the patient.
Additional Manufacturer Narrative
The reported complaint of fluid leakage and catheter lumens not functioning properly was not confirmed during visual and functional testing of the returned solex 7 catheter (lot #197459).No issues or discrepancies were found.No leak or malfunction was observed during testing, and the catheter functioned as intended.During the functional pressure leak test, all infusion ports and lumens were flushed without resistance and functioned as intended.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the serpentine balloon was fully inflated when pressurized up to 100 psi.No leaks or issues were found.No leak was observed from the insertion site (close to the manifold).The serpentine balloon did not leak during testing.In addition, the returned catheter was connected to a known- good suk and ran on a peristaltic pump for 10 minutes at a high-speed rate.No leak was observed, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system, running in the max warming mode with a target temperature at 37°c for 60 minutes and running in the max cooling mode with a target temperature at 35°c for 60 minutes.No leak was observed on the catheter.The serpentine balloon was properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning normally.No problem was found, and the catheter functioned as intended.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20645780
• Report Number: 3010617000-2024-00871
• Device Sequence Number: 7506180
• 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): 11/08/2024

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
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/08/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 140 KG