MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. SOLEX® INTRAVASCULAR HEAT EXCHANGE; 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	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a catheter leak was not confirmed during the visual inspection and functional testing of the returned solex 7 catheter (lot # 172888).No device malfunction was observed during the testing and the catheter functioned as intended.A visual examination of the returned catheter was performed.No physical damage to the catheter was found.Observed blood residue on the serpentine balloons and in luered tubings.Functional testing of the returned catheter was performed.All lumens are flushed without resistance.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi without any issues.The balloons did not leak during inflation and deflation.No crosstalk was observed.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.The catheter underwent additional functional testing using the known-good suk and the thermogard console in the max warming mode with a target temperature of 37°c for 60 minutes, then the max cooling mode with a target temperature of 35°c for 60 minutes.The balloons were properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning as normal.No leak was observed on the catheter.The catheter was performed as intended.
Event or Problem Description
During ivtm therapy for hypothermia after cardiac arrest a solex 7 catheter (lot #172888) was placed into the right subclavian vein, and the catheter insertion was smooth.The patient temperature at the start of ivtm therapy was 35.4°c, and the target temperature was set to 37.8°c.The dwell time of the catheter was 6 days.During the fever mode, when the patient's temperature was 36.8°c, the saline bag was noted empty and the thermogard console displayed a mid:09 (air trap assembly) message.No leaked fluid was observed on the patient bed, floor, and the thermogard console.A catheter leak and the infusion of the 200ml of saline fluid were suspected.The patient has already completed the rewarmed phase and the physician decided to stop treatment and the solex catheter was removed.Per the reporter, the mid:09 error was cleared, and the thermogard console was placed back for clinical use.The patient is well, and still in icu.No consequences or impact to the patient.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE
• 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: 20424660
• Report Number: 3010617000-2024-00807
• Device Sequence Number: 12866787
• 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): 10/10/2024

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: 11/02/2024
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 172888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 96 KG