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

Model Number	CL-2295AE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leaking cool line catheter (lot #80765) was confirmed during functional testing.A pinhole leak on the shaft was observed at 1cm away from the distal end of manifold.Visual inspection of the returned cool line catheter was performed and observed no physical damage.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The returned catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed.Thus, confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for cool line catheter with lot number 80765.
Event or Problem Description
During patient ivtm therapy for fever management, customer reported that the saline bag was empty after 2 hrs of dwell time.No saline fluid was observed on the floor, console or patient's bed.Customer suspected that the cool line heparin catheter (lot #80765) may have leaked.No other temperature management procedures performed.It was noted that the cool line catheter was inserted smoothly into the patient's left internal jugular vein.No known impact or consequence to patient information was available.

• 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: 8375008
• Report Number: 3010617000-2019-00127
• Device Sequence Number: 19364600
• 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
• Report Date (Section B): 02/27/2019

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: 80765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1