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

Model Number	IC-3893AE
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	09/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) at 9:40am the ivtm therapy was started with the thermogard xp ivtm system.The icy catheter (lot 184825) was inserted via left femoral.On (b)(6) at 9:50am, which was during the maintenance phase, the ccu chief nurse mr.Lai noticed the saline color in the saline bottle and start-up kit (suk) (lot 185648) tubing turned to light yellow(pink).After doing the leak check, the yellow(pink) saline was seen in the syringe, the chief nurse suspected leaking on the balloon catheter.During the time, there was no alarm on the console.The customer reported a decrease of around 20cc of saline in the saline bag and suspected 20cc of infusion into the patient's bloodstream.A new set of icy and suk was replaced at 11am on that day, and then ivtm therapy continued as intended until the end of the procedure.No impact to the patient.
Additional Manufacturer Narrative
The icy catheter in the complaint was discarded by the customer and will not be returned for investigation.Therefore, a physical investigation will not be performed.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18022197
• Report Number: 3010617000-2023-00913
• Device Sequence Number: 12396650
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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: IC-3893AE
• Device Catalogue Number: 8700-0695-40
• Device Lot Number: 184825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/27/2023
• 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