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	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint "the leak on the cool line catheter (lot # 151301)" was confirmed during visual inspection.The root cause for the reported complaint resulted from a circumferential tear, which was possibly caused by a latent material defect.Visual examination of the returned cool line catheter was performed, and blood was observed inside of the in/out luer tubing and inside of the balloons; this typically is indicative of a leak in the catheter.Further visual inspection revealed a circumferential tear at the proximal end of the distal balloon.The circumferential tear was clean.No other physical damage was observed on the catheter.A functional flushing test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance, except for the in/out luers due to the circumferential tear.Unable to perform the functional pressure leak test due to the condition that the cool line catheter was received.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 service information related to the reported complaint, and there was no previous history of complaint reported for the cool line catheter with lot number 151301.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals.In agreement with a customer, there was no patient's effect attributed to zoll catheter.
Event or Problem Description
A patient was admitted for fever control treatment using ivtm therapy.A cool line catheter (lot# 151301) was inserted into the patient's right subclavian vein with no unusual resistance noted.During the cooling phase, the thermogard system generated an air trap alarm, and the nurse noticed that the 500-ml saline bag was empty.The dwell time of the catheter was 72 hours when the issue was noted.The saline bag was removed, and a 1000-ml saline bag was placed.After a short period of time, it was noted that the second saline bag was half empty.There were no traces of fluid observed on the thermogard console, patient's bed, or floor.During further inspection, blood tinge was observed in the tubing.Therefore, catheter leak and infusion of about 1000 to 1500 milliliters of saline into the patient's bloodstream was suspected.The catheter was replaced, and the ivtm treatment continued successfully with the same thermogard console.The dwell time of the catheter was 144 hours at the time of removal.No malfunction was reported on the thermogard console and on the start-up kit (suk).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
• MDR Report Key: 10998568
• Report Number: 3010617000-2020-01237
• Device Sequence Number: 4496679
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 151301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1