MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7 CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the solex catheter (lot# 184662) was unable to flush was not confirmed during functional testing of the returned catheter.No issues or discrepancies were found.No device malfunction was observed during the testing.All the lumens were flushed without resistance 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.Observed blood had accumulated and dried up on the catheter's serpentine balloon and in luered tubings.A functional pressure leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.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 flow of saline was observed during testing, the catheter performed as intended.In addition, 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.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.The balloons were properly warming during the warming mode and cooling during the cooling mode.No leak, no damage was found on the catheter, and the catheter performed as intended.The suk red pinwheel and the pump roller were rotating as normal and the flow of saline was observed during testing, the catheter performed as intended.
Event or Problem Description
A patient underwent ivtm therapy for fever management.The solex 7 catheter (lot # 184662) was smoothly inserted into the patient's right internal jugular vein.The following day, the customer observed the pinwheel of the start-up kit (suk) (lot# unknown) not spinning.The in and out luers of the suk were disconnected from the catheter and re-connected together for testing purposes; however, there was no suk pinwheel rotation noted.The user was unable to flush the in and out luiers of the solex 7 catheter with the syringe.The patient's head was repositioned, and the user was able to flush the line with a significant effort.All infusion ports of the solex 7 catheter were flushed way easier than in and out luiers.The customer was advised to remove the catheter.The solex catheter was removed, and the new solex catheter was placed at the same site.The ivtm treatment was continued with no issues.No adverse event was reported.Per the reporter, the patient's treatment is ongoing with no issues or concerns reported.Per the nurse practitioner, the patient had been awake, alert, and moving before the issue occurred.She believes the observed issues were related to the patient's positioning and movement.

• Brand Name: ZOLL IVTM SOLEX 7 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18253258
• Report Number: 3010617000-2023-01017
• Device Sequence Number: 12423168
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 184662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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 Sex: Unknown