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

Model Number	CL-2295
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	05/23/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A patient with traumatic brain injury (tbi) underwent ivtm therapy to maintain normothermia.A cool line catheter (lot # unknown) was inserted into the patient's left subclavian vein with no issues.It was reported that the customer potentially powered injected contrast through the central line access.Four days after the initiation of the treatment, the thermogard system generated an "air trap" alarm.The staff noticed that the 500-ml saline bag had run empty.The staff replaced the saline bag and resumed the treatment.The customer did not perform a catheter leak check per the zoll's new ifu before replacing the saline bag.After about 3 to 4 hours, the thermogard system generated an "air trap" alarm again.The staff noticed that the second saline bag was also running empty.In addition, the staff observed blood-tinged saline in the start-up kit (suk) tubing, an indication of a catheter leak.An unknown amount of saline infusion into the patient's bloodstream is suspected.The staff placed the console into standby mode and removed the catheter.The ivtm therapy was not resumed, and no other temperature management devices were used, as the patient no longer needed temperature control treatment.There was no malfunction/issue reported on the thermogard console.No consequences or impacts on the patient.
Additional Manufacturer Narrative
The reported complaint of "catheter leak" was confirmed during the functional testing of the returned cool line catheter (lot # 162889).A pinhole leak was observed at the proximal end of the distal balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.Upon visual inspection, no physical damage was observed on the returned catheter.Dried blood residue was observed on the catheter balloons and inside the luered tubings.During functional testing, all infusion ports and extension tubes were flushed without resistance except for the distal and in/out luers due to blood clogging the lines.During the functional pressure leak test, the catheter was connected to a pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, a pinhole leak was observed at the proximal end of the distal 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 similar history of complaints reported for cool line catheter with lot number 162889.
Event or Problem Description
A patient with traumatic brain injury (tbi) underwent ivtm therapy to maintain normothermia.A cool line catheter (lot # 162889) was inserted into the patient's left subclavian vein with no issues.It was reported that the customer potentially powered injected contrast through the central line access.Four days after the initiation of the treatment, the thermogard system generated an "air trap" alarm.The staff noticed that the 500-ml saline bag had run empty.The staff replaced the saline bag and resumed the treatment.The customer did not perform a catheter leak check per the zoll's new ifu before replacing the saline bag.After about 3 to 4 hours, the thermogard system generated an "air trap" alarm again.The staff noticed that the second saline bag was also running empty.In addition, the staff observed blood-tinged saline in the start-up kit (suk) tubing, an indication of a catheter leak.An unknown amount of saline infusion into the patient's bloodstream is suspected.The staff placed the console into standby mode and removed the catheter.The ivtm therapy was not resumed, and no other temperature management devices were used, as the patient no longer needed temperature control treatment.There was no malfunction/issue reported on the thermogard console.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: 14739602
• Report Number: 3010617000-2022-00675
• Device Sequence Number: 16710393
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/22/2022

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-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 162889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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