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

Model Number	IC-4593
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 device associated with this complaint will not be returned for evaluation.Since the device was not returned, a physical investigation could not be performed and a root cause could not be determined.In the case the device is returned, the complaint will be re-opened to perform an investigation.
Event or Problem Description
The customer reported that during ivtm therapy the quattro catheter (lot# unknown) was placed in the left femoral vein.On the third day, the thermogard console generated an air trap alarm, and only 100ml fluid was observed inside the 500ml saline bag and there was a considerable amount of air in the air trap.Per the reporter, the thermogard console is functional after it generated an air trap alarm.There were no signs of fluid on the floor under or behind the console or inside of the air trap.There was some blood present in the start-up kit (suk) tubing.Ivtm therapy had been completed at the time of the event.Suspecting catheter leak and 400 ml of saline infusion.The customer was instructed to remove the catheter.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10624478
• Report Number: 3010617000-2020-00975
• Device Sequence Number: 2730176
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/03/2020

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: IC-4593
• Device Catalogue Number: 8700-0791-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1