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

Model Number	IC-3893
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	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll did not receive the catheter in the complaint for investigation.However, the customer returned the start-up kit (suk) (lot #194364) to zoll for evaluation, and the reported complaint was confirmed during the functional testing of the returned suk.During the peristaltic pump test, a leak was observed at the tubing to the suk's out luer connection.The probable root cause of the issue could be a latent defect in the bond.
Event or Problem Description
The icy catheter (lot #unknown) was used in an ivtm therapy.At some point during the treatment, the nurse noticed volume depletion on the saline bag without the thermogard system generating an "air trap" alarm.When zoll tech line called the customer, the nurse reported that the catheter had been removed due to a suspected leak.The customer did not report at what stage of therapy the issue was noted; however, the patient was warmed by the time the catheter was removed, and the treatment was completed.The patient no longer needed the ivtm therapy.There wasn't any blood noticed in the tubing prior to removal.The reporting registered nurse stated that the union of the catheter and start-up kit (suk) orange luers appeared to have been loose.However, they did not observe any saline leakage from the union of the catheter and suk orange luers.No issue was reported on the suk.The nurse reported no suspected patient harm.

• Brand Name: ZOLL IVTM ICY 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19188229
• Report Number: 3010617000-2024-00368
• Device Sequence Number: 20923047
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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