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	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cool line catheter associated with this complaint was discarded by the customer.Since the catheter was not returned, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
During ivtm therapy of the covid-19 patient, a cool line catheter was placed in a left internal jugular vein.The insertion was smooth.The patient's initial temperature was 37.3°c with a target of 37.2°c.During the cooling phase, three days after the treatment started, the thermogard console generated an air trap alarm and the 500ml saline bag was noted almost empty.The user replaced the saline bag and the start-up kit (suk), and the treatment was resumed utilizing the same console.However, the second 500ml bag was also noted losing the fluid volume.Per the physician's request, the treatment was stopped as the patient did not require more temperature management.The cool line catheter was not removed and was left as a central line until the seventh day of the patient's treatment.Per a reporter, there were no traces of fluid observed on the console, patient's bed, or floor around the patient; therefore, a catheter leak and infusion of about 350 - 400ml of saline into the patient's bloodstream was suspected.No consequences or impact to the patient.The cool line catheter was discarded by the customer as it was used to treat a covid-19 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: 11617389
• Report Number: 3010617000-2021-00287
• Device Sequence Number: 11583138
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 04/05/2021

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: 147213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 136