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

Model Number	8700-0781-40
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the cool line catheter for investigation.A supplemental report will be filed when the product investigation has ben completed.
Event or Problem Description
A (b)(6) years old male patient ((b)(6) kg) was hospitalized and underwent ivtm treatment with target temperature set to 34°c degree.Cool line catheter was inserted into the internal jugular left vein by a physician without issues.After 26 hours of the treatment, the blood was noted in the suk and catheter leak was suspected.The temperature was at 34°c degree when the issue was noted.Per reporter, the catheter was not removed.No other temperature management procedures was performed.The current condition of the patient is intubated.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported complaint was not confirmed.Unable to confirm the reported problem due to the condition in which the catheter was received.Visual inspection of the returned catheter was performed.The catheter was returned with a damaged shaft, the catheter was completely cut at 1 inch away from the distal end of the manifold.Blood had accumulated/dried up on the balloons.Unable to perform the pressurized functional testing due to the condition in which the catheter was received.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 a catheter with a lot number 80765.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8035710
• Report Number: 3010617000-2018-01117
• Device Sequence Number: 13811964
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 8700-0781-40
• Device Catalogue Number: 8700-0781-40
• Device Lot Number: 80765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 75