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

Model Number SL-2593AE

Device Problem Insufficient Cooling (1130)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the patient was not cooling using the solex catheter (lot 172888) 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 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 flow of saline 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 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 Description

During patient treatment for fever management, the solex 7 catheter (lot # 172888) was inserted into the internal right jugular vein.The insertion was smooth from the first attempt.After 5 hours of ivtm therapy, the patient was not achieving the target temperature of 33°c.The nurse noted that the flow indicator of the start-up kit (suk) was spinning, however, the patient's temperature was still at 37,8°c.A new icy catheter was placed to continue therapy utilizing the same suk.No alarm on the thermogard system and no leakage of saline fluid was observed.The patient reached the target temperature.No injury or adverse impact was reported.The patient is stable.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Type of Device: 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: 17331450
• MDR Text Key: 319097285
• Report Number: 3010617000-2023-00601
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1