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	Brain Injury (2219)
Date of Event	07/16/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll has not received the cool line catheter for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.Seems that the patient could receive amount of one bag of sterile saline.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.The fluid ran into the patient's vasculature is an anticipated event.No patient's effect was observed.Death not related to zoll device.The date of death is unknown.
Event or Problem Description
The patient was hospitalized post-cardiac arrest in the field after the motorcycle accident with the traumatic brain injury (tbi).The cool line catheter was inserted into the patient's left femoral vein.During the ivtm therapy, the user observed an empty saline bag due to the catheter leak.No further information was provided by the customer.The patient was diagnosed as brain dead.

• 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: 12363563
• Report Number: 3010617000-2021-00765
• Device Sequence Number: 17116403
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CL-2295
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 159575
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death