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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The cool line catheter (lot # 162565) was used for therapeutic hypothermia management therapy.During the treatment, the customer noticed that a significant amount of saline had depleted from the saline bag.The customer removed the catheter and inspected the start-up kit (suk) tubing to troubleshoot the issue and find the source of the leak.But, no evidence of leak was observed, and there was no change in saline meniscus level, indicating no loss of fluid.The customer then re-connected the cool line catheter to the system and restarted the treatment.However, the customer observed a hole in the catheter balloon, spurting out saline.No further information was provided.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has not received the catheter in complaint for investigation.A follow-up report will be submitted if and when the product is returned, and an investigation has been completed.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated based on the received additional information.H6 (health effect - clinical code) was corrected based on the received additional information.H6 (health effect - impact code) was corrected based on the received additional information.
Event or Problem Description
The cool line catheter (lot # 162565) was smoothly inserted into the patient's right femoral vein for therapeutic hypothermia management therapy.Approximately 1 hour after the initiation of the treatment, the thermogard console generated an "air trap" alarm.Subsequently, the console's pump rotor stopped, and the system went into standby mode.The customer noticed that the 500-ml saline bag was empty.The customer stated that there were no issues with the start-up kit (suk), and its pinwheel was rotating as intended.The customer replaced the saline bag and resumed treatment.About 10-15 minutes later, the staff came back to the room and observed that the second saline bag was also empty.The customer did not report if the staff heard any alarms.The thermogard console was stopped, and the customer replaced the saline bag again.The customer removed the catheter and inspected the start-up kit (suk) tubing to troubleshoot the issue and find the source of the leak.But, no evidence of a leak was observed, and there was no change in saline meniscus level, indicating that there was no saline leak or drop in saline level.The customer then re-connected the cool line catheter to the thermogard system and restarted the treatment.Within minutes, the staff noticed the saline bag volume had begun to decrease.The staff checked all connections, including a thorough inspection of the cool line catheter, and found a leak at the catheter, spurting out saline into the patient's bed.There was no suspected saline infusion into the patient's bloodstream as saline was leaking out from the external part of the catheter.The customer replaced the catheter.The treatment continued and was completed successfully using the same thermogard console and suk.No consequences or impacts on 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15541348
• Report Number: 3010617000-2022-01725
• Device Sequence Number: 12161029
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/20/2022

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: 162565
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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