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

Model Number	SL-2593
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	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A patient underwent ivtm therapy for fever management.The solex 7 catheter (lot # unknown) was smoothly inserted into the patient's right internal jugular vein in a single insertion attempt.There was no arterial catheter placed for medical reasons.Shortly after starting the treatment, the customer noticed a decrease in the saline bag, except for the 200-250 ml circulating in the tubing.The customer noticed this issue before the thermogard system display an "air trap" alarm.The customer observed saline on the patient's bed, and there was no blood tinge in the suk tubing.The customer suspected that the issue was related to the suk luers, so, they replaced the start-up kit (suk) (lot # unknown) along with the saline bag.However, the problem was not resolved, and saline started to decrease again in the saline bag.The customer contacted zoll tech line support and reported experiencing a potential defect in the catheter lumen, causing a saline leak.The customer did not suspect any saline infusion into the patient's bloodstream but was concerned about a potential issue with the catheter.The zoll clinical field personnel advised the customer to replace the catheter at the physician's discretion.The catheter was replaced, and the treatment was continued and completed using the same thermogard console.The customer did not report any suspected patient injury.
Additional Manufacturer Narrative
The reported complaint of "a potential defect in the catheter lumen, causing saline leakage" was confirmed during functional testing of the returned solex 7 catheter (lot # 171267).A leak was observed from the "in" lumen tubing during the functional pressure leak test.The root cause of the reported complaint was a small sharp cut, located 1.5 cm away from the distal end of the "in" luer port.The cause for the sharp cut could not be conclusively determined; however, using sharp tools such as a scalpel may have accidentally cut the lumen.During visual inspection, dried blood residue was observed in the serpentine balloon and inside the luered tubings.No other issues or apparent physical damage were found.During functional testing, all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device to perform the pressure leak test.Upon pressurizing the catheter, a leak from the "in" lumen tubing was observed, at 1.5 cm away from the distal end of the "in" luer port, confirming the reported complaint.The "in" lumen tubing was inspected under the microscope, and a very small sharp cut was observed on the tubing.There was no leakage from the serpentine balloon.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints for solex 7 catheter with lot number 171267.
Event or Problem Description
A patient underwent ivtm therapy for fever management.The solex 7 catheter (lot # 171267) was smoothly inserted into the patient's right internal jugular vein in a single insertion attempt.There was no arterial catheter placed for medical reasons.Shortly after starting the treatment, the customer observed a decrease in the saline bag, except for the 200-250 ml circulating in the tubing.The customer noticed this issue before the thermogard system generated an "air trap" alarm.There was no blood tinge in the tubing.The customer observed saline was leaking at the union of the catheter and suk orange luers.There was saline on the patient's bed.The customer replaced the start-up kit (suk) along with the saline bag.However, the problem was not resolved, and the saline level decreased again.The customer contacted zoll tech line support and reported experiencing a potential defect in the catheter lumen, causing saline leakage.The customer did not suspect any saline infusion into the patient's bloodstream but was concerned about a potential issue with the catheter.The zoll clinical field personnel advised the customer to replace the catheter at the physician's discretion.The catheter was replaced, and the treatment was continued and completed using the same thermogard console.The customer did not report any suspected patient injury.

• Brand Name: ZOLL IVTM SOLEX 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: 16607918
• Report Number: 3010617000-2023-00300
• Device Sequence Number: 4854881
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 171267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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