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	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported that the patient was admitted for ivtm therapy after experiencing cardiac arrest on march 18th.A solex 7 catheter (lot # unknown) was inserted into the patient's right internal jugular vein by an advanced practice provider (app).Catheter insertion was smooth and completed in one attempt.After placing an arterial catheter for medical purposes, therapeutic hypothermia was initiated on march 18th at 23:14.The catheter was functioning without any issue until march 20th at around 12:30 pm, when the bedside nurse observed blood in the start-up kit (suk) tubing.As reported, the thermogard console had not generated any "air trap" alarm before the issue was noticed.Upon further inspection, the nurse noticed that the 500-ml saline bag had run dry, which raised concerns about a potential balloon rupture.The bedside nurse immediately notified the nurse practitioner (np), who removed the catheter from the patient.Infusion of about 250 milliliters of saline into the patient's bloodstream was suspected (200-250 ml of saline in the 500-ml saline bag circulates in the closed-loop system).The treatment had been completed, and the patient was being maintained on the system for normothermia.Therefore, the catheter was not replaced, and the treatment was discontinued.The np stated while flushing the catheter post-removal, the leak appeared halfway down the balloon.There was no harm to the patient.

• 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 95131 ; 4084192922
• MDR Report Key: 16748044
• Report Number: 3010617000-2023-00346
• Device Sequence Number: 3365827
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/14/2023

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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