MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	IC-4593AE
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	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will not be returning the zoll catheter for investigation.Therefore, physical investigation could not be performed, and the root cause could not be determined.Event of death was serious because it met criteria for seriousness (death).The patient was in a critical condition and eventually expired.According to the reporter, the patient outcome of death was not attributed to zoll device.Usually critically ill patients receive ivtm therapy and mortality rate is high.Probably outcome death related to the patient's clinical condition and not to ivtm therapy.Death was not related to zoll device.
Event or Problem Description
An ivtm therapy was initiated for a 62-year-old male patient (weight: 110 kg), and the primary cause of hospitalization and need for ivtm therapy was severe hypothermia.A quattro catheter (lot #201328) was inserted smoothly into the patient's left femoral vein.At the start of ivtm therapy, the patient's temperature was 29.2°c, and the target temperature was 36°c at 0.5°c/hour.During the therapy, the thermogard xp ivtm system generated an "air trap warning" alarm, and the customer noted a decreasing volume of saline in the saline bag.No leaked fluid was observed on the thermogard system, patient bed, floor, etc.The temperature at the time of the issue was 30.1°c, and the dwell time of the catheter was 2 hours.The patient died in the course of his its (intensive care unit) treatment and during the rewarming phase of the ivtm therapy.As a criminal case cannot be ruled out as the cause of his hospitalization, the quattro catheter could not be removed according to the instructions of the german police and the law.The cause of death was due to severe hypothermia and the overall very poor general condition of the patient or the severity of the current illness as an expression of a life-threatening situation, which was not survived in this case.The death of the patient is expressly not related to the ivtm therapy.

• Brand Name: QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20730656
• Report Number: 3010617000-2024-00912
• Device Sequence Number: 12985169
• Product Code: NCX
• UDI-Device Identifier: 00849111075275
• UDI-Public: 00849111075275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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 Expiration Date: 03/03/2026
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 201328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 110 KG