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

Model Number	CL-2295AE
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a complaint that "cooling the patient took longer than usual" was not confirmed during the visual and functional testing of the returned cool line catheter (lot #183057).No device malfunction was observed during the testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.There were no kinks or physical damage observed on the catheter.Blood residues were observed on the balloons and in the proximal luer tubing.A functional pressure leak test of the returned catheter was performed.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 observed.The balloons did not leak during inflation and deflation.In addition, the returned catheter was connected to a known good start-up kit (suk) and ran on a peristaltic pump for 10 minutes at a high-speed rate.No leak or damage was found.The red pinwheel was rotating as normal, and the saline flow was observed during testing; the catheter performed as intended.During further functional testing, the returned catheter was connected to a known good suk and ran on the thermogard xp ivtm 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.The balloons were properly warming during the warming mode and cooling during the cooling mode.No leak or damage was found on the catheter, which performed as intended.The suk red pinwheel and the pump roller were rotating as normal, and saline flow was observed during testing; the catheter performed as intended.
Event or Problem Description
During the ivtm therapy for a large patient weighing 17 stone (238 lbs.) using the cool line catheter (lot #183057), the customer reported that cooling the patient took longer than usual.The patient's body temperature at the initiation of cooling was about 39°c.The red pinwheel in the start-up kit (suk) was not rotating, and the saline wouldn't circulate through the tubing.There was no kink noted on the catheter.The customer tried two different thermogard xp ivtm systems and two different suks using the same catheter, and the issue persisted.The suk pinwheel did not rotate both times, and the saline wouldn't circulate through the tubing.The doctors waited to see if the patient's temperature dropped without needing to insert a new catheter & it did.Therefore, the treatment was stopped.The customer said the issue was possibly due to using a small catheter.The ambient room temperature is also higher than usual due to the weather.No patient injury was reported.

• Brand Name: ZOLL IVTM COOL LINE 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: 17329694
• Report Number: 3010617000-2023-00619
• Device Sequence Number: 12146774
• Product Code: NCX
• UDI-Device Identifier: 00849111075060
• UDI-Public: 00849111075060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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: CL-2295AE
• Device Catalogue Number: 8700-0654-40
• Device Lot Number: 183057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2022
• 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
• Patient Weight: 108 KG