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 Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the cool line catheter (lot # 96693) for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
During ivtm therapy, the physician placed a first cool line catheter (lot # 96693) into patient's subclavian vein.The user observed blood backing up into the start-up kit (suk) tubing.The physician replaced the first cool line catheter with the second cool line catheter (lot # 96693) and observed blood backing up into the start-up kit (suk) tubing.Suspecting catheter balloon breach.The ivtm treatment was discontinued and the patient treatment was continued with an alternate temperature management method.Per user, the physician chose to use the cool line catheter because the patient had wounds in the groin, and the hospital does not have solex catheter.No device malfunction was reported for the thermogard xp ivtm system.No patient consequence was reported.Please see the following related mfr report: mfr 3010617000-2020-00081 for the first cool line catheter.
Additional Manufacturer Narrative
The reported complaint was unable to be confirmed and a root cause could not be conclusively determined.Upon visual inspection, observed dried blood residue on the cool line catheter (lot # 96265) balloons and noticed that the in/out luered tubing's are clogged up with dried blood.All infusion ports and extension tubes were flushed without resistance, except the in/out luered tubing's due to the obstruction.Unable to perform functional testing due to the clogged up in/out luered tubing's.
Event or Problem Description
During ivtm therapy, the physician placed a first cool line catheter (lot # 96265) into patient's subclavian vein.The user observed blood backing up into the start-up kit (suk) tubing.The physician replaced the first cool line catheter with the second cool line catheter (lot # 96265) and observed blood backing up into the start-up kit (suk) tubing.Suspecting catheter balloon leak.The ivtm treatment was discontinued and the patient treatment was continued with an alternate temperature management method.Per user, the physician chose to use the cool line catheter because the patient had wounds in the groin, and the hospital does not have solex catheter.No device malfunction was reported for the thermogard xp ivtm system.No consequences or impact to the patient was reported.Please see the following related mfr report: mfr 3010617000-2020-00081 for the first cool line catheter.
Additional Manufacturer Narrative
Correction in h6.The functional testing of the returned cool line catheter (lot # 96265) could not be performed due to the clog accumulation in the in/out luered tubings.However, blood was observed inside of the in/out luer tubing and inside of the balloons, this typically is indicative of a leak somewhere in the catheter.Also, the customer noticed blood in the suk tubing, which is the characteristic of catheter balloon breach.Specific location or type of leak is undetermined due to the condition in which the catheter was received.

• 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: 9645192
• Report Number: 3010617000-2020-00082
• Device Sequence Number: 1965068
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/11/2020

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-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 96265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/03/2020; 03/10/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/19/2020; 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1