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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of catheter leak was confirmed during the functional testing of the returned icy catheter (lot #196563).A water emission/leak was observed from the proximal luer port during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Upon visual inspection, no physical damage was observed to the catheter.Dried blood residue was observed in the proximal luered tubings.All infusion ports and lumens were flushed without resistance during functional testing of the returned catheter.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.No leak was observed from the catheter balloons.However, a water emission/leak was observed from the proximal luer port during the lumen crosstalk test, confirming the reported complaint.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 was no previous history of complaints for the icy catheter with lot number 196563.
Event or Problem Description
The icy catheter (lot #196563) was inserted into the patient's right femoral vein to initiate an ivtm therapy.Four hours later, the cooling target temperature of 33 °c was achieved.After about 16 hours into the treatment, during the maintenance phase after cooling, the nurse observed a significant decrease in the level of saline solution in the 500-ml saline bag.Around 100 milliliters of saline were lost from the bag, suspected to have infused into the patient's bloodstream.The physician decided to end the temperature management treatment procedure due to the patient regaining consciousness.Before removing the catheter, a catheter leak check was performed following zoll ifu instructions.A red/blood tinge in the turning was observed, indicating a leak from the catheter.No consequences or impacts on the patient.

• 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: 19347101
• Report Number: 3010617000-2024-00403
• Device Sequence Number: 11434334
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 196563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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