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

Model Number	CL-2295
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 03/29/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
The patient was inserted a coolline catheter in the internal jugular vein without any reported issue and received ivtm therapy.Per report, on day 6 the user observed that the fluid level of the saline bag was emptying.No signs of leak on the suk or on the patient's bedside was observed.The user decided to replace the saline bag; however, this did not resolve the issue.A catheter leak was suspected.Following this, ivtm therapy was discontinued as the patient had already achieved target rewarming temperature.The cool line catheter was removed without issue.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Corrected lot number.The reported complaint was confirmed.Visual examination found no physical damage.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a bond leak was observed on the proximal balloon, distal end.During manufacturing all cool line catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect.

• 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: 7467397
• Report Number: 3010617000-2018-00410
• Device Sequence Number: 16345275
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 8700-0654-01
• Device Lot Number: 63835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1