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

Model Number	CL-2295AE
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	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the leak at the distal and proximal infusion luers of the cool line catheter (lot # 173265) was confirmed during the visual inspection and functional testing.Both distal and proximal infusion luers on the catheter were cracked.The probable root cause for the cracked luers could be due to a latent material defect or due to over torqueing of the luer connectors.Visual inspection of the returned catheter was performed and found the distal and proximal infusion luers were cracked.In addition, unrelated to the reported complaint, the shaft of the catheter was cut 14 cm away from the manifold by the customer before the item was shipped for evaluation.During the functional testing, the returned catheter was connected to the syringe, and upon applying the pressure, a leak was observed at the distal and proximal infusion luers; thus, confirming the reported complaint.No further testing of the returned catheter could be performed due to the condition in which the catheter was received.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.It is unlikely that the defective catheter was shipped.Historical complaints were reviewed for information related to the reported complaint and there was no similar complaint reported for the cool line catheter with lot number 173265.
Event or Problem Description
A 68 years old female patient underwent ivtm therapy for hypothermia.The cool line catheter (lot # 173265) was inserted into the patient's subclavian vein.At the start of ivtm therapy, the patient's temperature was 36.7°c.On (b)(6) 2023, the nurse noticed a leak at the distal infusion luers connection.Per the reporter, the distal infusion port was used to deliver the nimotop medication.The line was disconnected, and the medication was switched to the proximal infusion luer.On (b)(6) 2023, eleven days after the leak incident, the second leak was observed at the proximal infusion lumen connection.The catheter was replaced.The therapy is still ongoing.No consequences or impact to the patient.
Event or Problem Description
The ivtm therapy was performed on a 68-year-old female patient to induce hypothermia.The cool line catheter (lot # 173265) was inserted into the patient's subclavian vein.At the start of ivtm therapy, the patient's temperature was 37.6°c.On (b)(6) 2023, the nurse noticed a leak at the distal infusion luers connection.Per the reporter, the distal infusion port was used to deliver the nimotop medication.The line was disconnected, and the medication was switched to the proximal infusion luer.On (b)(6) 2023, eleven days after the leak incident, the second leak was observed at the proximal infusion lumen connection.The catheter was replaced.The therapy is still ongoing.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM COOL LINE 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: 17101823
• Report Number: 3010617000-2023-00509
• Device Sequence Number: 7803196
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: CL-2295AE
• Device Catalogue Number: 8700-0781-40
• Device Lot Number: 173265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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 Age: 68 YR
• Patient Sex: Female