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 Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the cool line catheter (lot # 98337) was confirmed during the functional testing.A pinhole leak was observed at the proximal end of the proximal balloon.The probable root cause for the balloon pinhole could be due to latent material defect.Upon visual inspection, noticed a knot on the medial luered tubing.In addition, noticed dried blood on the catheter balloons and on the medial, proximal and in luered tubing's.The probable cause for the knot on the luered tubing could be due to user mishandling.During functional testing, all infusion ports and extension tubes were flushed without resistance, except the medial luered tubing due to the knot.The catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the proximal end of the proximal balloon.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 # 98337.
Event or Problem Description
During ivtm therapy for a patient with hypothermia, the user observed empty saline bag and noticed blood flow from the out luer of the cool line catheter (sn (b)(4)).Suspecting catheter leak.The dwell time of the catheter was 120 hours.The patient temperature at the start of the therapy was 36.4°c.The target temperature was 33°c and the temperature at the time of the issue was 36°c.The catheter was not removed and was continued to be used as a central venous catheter.The patient treatment was continued with alternate temperature management method.No patient consequence was reported.

• 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: 9640041
• Report Number: 3010617000-2020-00051
• Device Sequence Number: 16840158
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 98337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1