MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
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	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The icy catheter (lot #184646) and start-up kit (suk) (lot #185649) were utilized to provide ivtm therapy to a post-cardiac arrest patient.Approximately 24 hours after starting the ivtm therapy, the customer noticed that the saline solution in the bag had turned yellow.The customer felt the volume of the saline solution in the bag appeared to have decreased to 150 ml.No "air trap" alarm was reported to have been displayed by the thermogard console.There were no reports of saline solution on the patient's bed, floor, or console.Upon follow-up, it was confirmed that the saline bag was properly spiked, and the customer was aware that around 200-250 ml of saline solution had circulated in the tgxp closed-loop system.There were no reports of potential saline infusion into the patient's bloodstream.Despite the absence of confirmed saline infusion into the patient's bloodstream or any clear signs of a leak from the system, the customer was concerned about a potential catheter leak.The customer replaced both the icy catheter and the suk and completed the treatment with the same thermogard console.No patient injury was reported.
Additional Manufacturer Narrative
The reported complaint of a "potential catheter leak" was not confirmed during visual and functional testing of the returned icy catheter (lot #184646).No issues or discrepancies were found on the catheter.No leak or malfunction was observed during testing, and the catheter functioned as intended.Visual examination of the returned catheter found no physical damage.A discoloration (yellow-orange) color was observed inside the balloons and in the in/out lumen tubings.During the functional pressure leak test of the returned catheter, all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi, and no issues were found.The balloons 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 testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system in both warming and cooling modes for 2 hours.The system ran in the max warming mode with a target temperature of 37°c for 60 minutes and in the max cooling mode with a target temperature of 35°c for 60 minutes.No leak was observed on the catheter.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 problem was found, and the catheter functioned as intended.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17738095
• Report Number: 3010617000-2023-00781
• Device Sequence Number: 6668946
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/13/2023

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-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 184646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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