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	03/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot # 178513) was confirmed during functional testing.A bonding leak was observed at the proximal end of the distal balloon during the functional pressure leak test.The probable root cause could be a latent defect at the bond.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100psi, a bonding leak was observed at the proximal end of the distal balloon, thus 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 similar complaint reported for the icy catheter with lot # 178513.
Event or Problem Description
A patient underwent ivtm therapy for hypothermia at 13:50 on march 24th.At 16:00 on the same day, it was noticed that the start-up kit (suk) (lot# 180079) pinwheel was not spinning.The physician adjusted the icy catheter (lot# 178513) by pulling it out around 4cm, after which the pinwheel started to rotate.At 05:30 on march 25th, the tubing connection of the suk at the check valve became disconnected.The physician reconnected it, and the system resumed normal operation.Later, at 18:50 on march 25th, the user noticed a decrease in saline, but there were no signs of saline on the floor or bed.A new suk was installed, but the saline levels continued to decrease.Following the "leak investigation instruction," all connections were checked, but nothing abnormal was found.The customer followed the ifu and did not replace the saline bag prior to the leak investigation.The icy catheter was replaced and the treatment continued.No consequences or impact to 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16793337
• Report Number: 3010617000-2023-00362
• Device Sequence Number: 12484844
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2023

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 178513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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