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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the cool line catheter (lot# 147000) for investigation.A follow-up report will be submitted when the catheter is returned, and the investigation has been completed.
Event or Problem Description
After 10 hours of ivtm therapy, the user observed saline bag was low at approximately 250 ml.User did not observed any leaks around the patient, bed side or console; suspecting a cool line catheter (lot#147000) leak.The following day, after the patient had coughing/vomitting episode, the suk tubing was observed with blood in it, discontinued the therapy, and removed the catheter.No consequences, or impact to patient.
Additional Manufacturer Narrative
The reported complaint of cool line catheter leak was confirmed.A balloon tear was observed at distal end of distal balloon during in/out luers flushing.Probable causes for the reported complaint can be a latent material defect.Visual examination of the returned catheter was performed.Observed blood in the catheter balloon and in in/out and proximal luered tubings.Further visual inspection was observed using a microscope and the tear on the balloon was observed clean, the tear located at distal end of distal balloon.No other physical damage was observed on the catheter.Functional leak test of the returned catheter was performed.A leak was observed at distal end of distal balloon during in/out luers flushing.All lumens were flushed without resistance, except in/ out luers due to the tear on the balloon, thus confirming customer complaint.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 similar complaint reported for a catheter with a lot number 147000.

• 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: 10759994
• Report Number: 3010617000-2020-01097
• Device Sequence Number: 1125365
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 147000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1