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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "leaking cool line catheter (lot# 145995)" was confirmed during the functional testing of the returned catheter.A pinhole leak was observed at the middle of the distal balloon.The probable root cause of the pinhole leak was a latent material defect.Visual examination of the returned catheter was performed, and no physical damage was found on the catheter.The balloons were examined, and blood residue was observed on the balloons.Functional testing of the returned catheter was performed, and all lumens were flushed without resistance.The catheter was connected to a pressurized inflation device for one minute, the balloons were fully inflated when pressurized up to 100 psi.Immediately upon pressurizing the catheter, a pinhole leak was observed at the middle of the distal balloon; thus, confirming the reported complaint.It is unlikely that the defective catheter was shipped.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 information related to the reported complaint, and there was no previous history of complaint reported for cool line catheter with lot number 145995.
Event or Problem Description
A patient was admitted for fever control treatment using ivtm therapy.A cool line catheter (lot# 146259) was inserted into the patient's left jugular vein, with no unusual resistance noted.No other central line was placed after the cool line catheter was inserted.After about 70 hours, during the maintenance phase, the thermogard xp ivtm system generated an "air trap" alarm, and the nurse noticed that the 500 ml saline bag was empty.There were no traces of fluid observed on the thermogard console, patient's bed, or floor.Catheter leak and infusion of about 500 milliliters of saline into the patient's bloodstream was suspected.Since the patient did not need further treatment, the catheter was removed, and the therapy was ended.No device malfunction was reported on the thermogard console.No consequences or impact to the patient.

• 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: 10623749
• Report Number: 3010617000-2020-00966
• Device Sequence Number: 3158834
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: 145995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1