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	07/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "saline bags had emptied" was confirmed during functional testing.A bonding leak was observed at the proximal end of the medial balloon during the functional pressure leak test of the returned icy catheter (lot # 188015).The probable root cause of the reported complaint could be a latent defect in the bond.A visual inspection of the returned catheter was performed and found no physical damage to the catheter.Dried blood residue was observed inside balloons and luer tubings.During functional testing, all infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, a bonding leak was observed at the proximal end of the medial balloon, 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 reported for the icy catheter with lot number 188015.
Event or Problem Description
The icy catheter (lot # 188015) was inserted into the patient's femoral vein for ivtm therapy.During the maintenance phase of the treatment, the thermogard console displayed an "air trap" alarm.The nurse observed blood in the start-up kit (suk) tubing and noticed that the saline bag had emptied.The nurse replaced the saline bag and resumed the therapy.However, the 2nd saline bag ran empty as well.The nurse contacted zoll clinical team and was advised to remove the catheter.The customer did not provide any further information.The reported incident did not cause any harm to the patient.
Event or Problem Description
The icy catheter (lot # 188015) was inserted into the patient's femoral vein for ivtm therapy.During the maintenance phase of cooling, the thermogard console displayed an "air trap" alarm.The pump rotor stopped, and the console went into standby mode.The nurse observed blood in the start-up kit (suk) tubing and noticed that the 500-ml saline bag had emptied.The nurse replaced the saline bag to resume the therapy.Initially, it was reported that the second saline bag ran empty as well.However, upon follow-up, the customer stated that after replacing the first saline bag, they contacted the zoll immediately.The zoll clinical team advised the customer to remove the catheter.The dwell time of the catheter was about two days (less than 24 hours).The catheter was replaced, and the treatment continued and was completed with the same thermogard console.The customer suspected an infusion of 500 milliliters of saline into the patient's bloodstream.The reported incident did not cause any harm to the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated and corrected based on the received additional information.

• 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 nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17409826
• Report Number: 3010617000-2023-00633
• Device Sequence Number: 5962304
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 188015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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