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	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of balloons appeared ruptured from the cool line catheter (lot # 172802) was confirmed during functional testing.A leak was observed from the proximal end of the distal balloon due to a balloon tear.The probable root cause of the reported complaint was a latent material defect.Upon visual inspection, no physical damage was observed.Blood residues were noticed inside the catheter's balloons and the distal luered tubing.During functional testing, all infusion ports and extension tubes were flushed without resistance.Upon flushing the in/out lumens, the leak was observed from the proximal end of the distal balloon, confirming the reported complaint.During further inspection of the catheter under a microscope, a balloon tear was observed at the proximal end of the distal balloon.No further functional testing was performed due to the discovered/confirmed leak.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 following process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for the cool line catheter with lot number 172802.Seems that around 1000 ml of sterile cold saline was entered the patient's vasculature.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.The customer will benefit from additional training on how to handle suspected catheter leak.The fluid ran into the patient's vasculature is an anticipated event.Based on available information, no patient's effect was observed.The reported event is causal related to the device and procedure.
Event or Problem Description
During ivtm therapy on a patient with traumatic brain injury (tbi) for fever control, patient was successfully being managed at target ranges until the thermogard ivtm system generated an "air trap warning" alarm.The customer noticed blood-tinge backing up in start-up kit (suk) tubing, and empty1000ml saline bag.The suk and saline bag were replaced, primed and hooked to patient, blood-tinge was noticed again in the suk tubing.The customer tried to run the thermogard ivtm system a few times but was unsuccessful due to "air trap warning" alarms.The customer removed cool line catheter (lot #172802) from the patient's left subclavian vein and observed internal balloons appeared ruptured.A experienced physician attempted to insert a new cool line catheter over guidewire but was unsuccessful, as the catheter could not get to thread into the patient.Another temperature management was utilized to continue with treatment.There was no power injection, rapid transfusion, or other lines in same insertion site.It is unknown how much saline was infused into the patient.No consequences or impact to the patient.Please see the following related mfr report: mfr (b)(4) for thethermogard ivtm system (sn unknown).

• 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: 15397492
• Report Number: 3010617000-2022-01528
• Device Sequence Number: 14726966
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: 172802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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