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	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cool line catheter in complaint was returned incomplete.Therefore, functional testing could not be performed.A visual inspection of the returned catheter was performed.Cool line catheter was returned without the catheter tip.The catheter tip was completely cut off from the distal end of the distal balloon.Unable to perform the pressurized functional testing due to the condition in which the catheter was received.Per zoll medical safety assessment, the patient tolerated temperature management well.Insertion of 100 ml of sterile saline over 24h in the patient's vasculature could not potentially harm the patient.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals.Reporter stated that the icy catheter did not contributed to the patient's outcome and the patient doing well.In agreement with a customer, there was no patient's effect attributed zoll catheter.
Event or Problem Description
As reported, after 4 day of ivtm therapy, the thermogard console displayed air trap alarm and the user replaced the saline bag.User did not observe any leak on the suk and no liquid on the floor, indicating a balloon leak on the coolline catheter.The user observed saline bag loses about 100 ml of saline per day.The target temperature was 36°c and the temperate at the time of issue was 36°c.The catheter was replaced and therapy was continued.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
Additional information: the catheter tip was cut off by the hospital staff as a standard procedure for microbial analysis.This is not a product failure.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9869523
• Report Number: 3010617000-2020-00309
• Device Sequence Number: 10911611
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 83270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1