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	Insufficient Information (4580)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During ivtm therapy on a (b)(6) years old female admitted for an intracerebral aneurysm and had a cardiac arrest during an earlier surgery.The insertion of the cool line catheter was smooth in the patient's left femoral vein.A day after treatment was initiated, saline fluid was noticed on a laid disposable pad where the luer connection of the cool line catheter (lot #unknown) and the start-up kit (suk) (lot #unknown) sat on the patient's bed.The nurse reported that the zoll catheter or start-up kit tubing leaking onto the bed overnight and still leaking in the morning.One saline bag had been changed overnight due to going empty.During the reported leaking, the patient had no issues maintaining target temperature with the thermogard console.Zoll clinical field specialist (cfs) was on the customer site at the time of the reported event and examined the catheter, suk and saline bag, found no leak or breech.Then, the zoll cfs locked the connection between the catheter and the suk and restarted the thermogard console, no leak was observed from the luers/connection area.The catheter balloons were deflated/inflated , and no blood was observed.The suk appeared normal with no breakage.The zoll cfs disconnected/reconnected the orange luers of the catheter and suk to ensure they were aligning properly, which they were.Following this, zoll cfs changed out the suk to a new one to test the catheter.Zoll cfs could reproduce the issue of saline leaking out of orange luers even with the new suk.The catheter's orange luer suspected to have caused the leak.The saline bag, suk and the catheter were replaced and treatment continued with the same thermogard console.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has received the catheter however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint that the leak from the luer connection of the cool line catheter (lot #155753) was confirmed during visual inspection and functional testing.The "in" luer lock connection on the catheter was cracked, scratched and dented.The probable root cause for the cracked luer could be due to a latent material defect or due to over torqueing of the luer.Visual inspection of the returned catheter was performed and found the "in" luer lock connection was cracked, scratched and dented.No other physical damage was observed.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The returned catheter was connected to the pressurized inflation device and upon pressurizing the catheter, a water/emission/leak was observed at the "in" luer lock connection; thus, confirming the reported complaint.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 previous history of complaint reported for a catheter with a lot number 155753.
Event or Problem Description
During ivtm therapy on a 66 years old female admitted for an intracerebral aneurysm and had a cardiac arrest during an earlier surgery.The insertion of the cool line catheter was smooth in the patient's left femoral vein.A day after treatment was initiated, saline fluid was noticed on a laid disposable pad where the luer connection of the cool line catheter (lot #155753) and the start-up kit (suk) (lot #165115) sat on the patient's bed.The nurse reported that the zoll catheter or start-up kit tubing leaking onto the bed overnight and still leaking in the morning.One saline bag had been changed overnight due to going empty.During the reported leaking, the patient had no issues maintaining target temperature with the thermogard console.Zoll clinical field specialist (cfs) was on the customer site at the time of the reported event and examined the catheter, suk and saline bag, found no leak or breech.Then, the zoll cfs locked the connection between the catheter and the suk and restarted the thermogard console, no leak was observed from the luers/connection area.The catheter balloons were deflated/inflated , and no blood was observed.The suk appeared normal with no breakage.The zoll cfs disconnected/reconnected the orange luers of the catheter and suk to ensure they were aligning properly, which they were.Following this, zoll cfs changed out the suk to a new one to test the catheter.Zoll cfs could reproduce the issue of saline leaking out of orange luers even with the new suk.The catheter's orange luer suspected to have caused the leak.The saline bag, suk and the catheter were replaced and treatment continued with the same thermogard console.Patient's status information was requested but the customer did not provide a response.

• 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: 13849240
• Report Number: 3010617000-2022-00261
• Device Sequence Number: 19980950
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/15/2022

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: 155753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: 66 YR
• Patient Sex: Female