MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. START-UP KIT CUSTOM LUER; SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING

Model Number	CG-500D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ttm therapy (targeted temperature management) running as ordered since 0845; at approximately 1000, rn (registered nurse) noted fluid in tubing and iv bag to be yellow in color, was previously clear; ttm therapy stopped, provider notified; zoll clinical rep notified and instructed to remove start-up kit/tubing and reinitiate therapy with a new kit and new iv bag; catheter checked per clinical rep directions with no issues noted, no blood noted with pulling back on the catheter ''in" port with designated syringe; new start kit primed and set up and therapy re-initiated with no issues; per instruction, start-up kit and fluid bag saved in biohazard bag to send to the company for inspection.Manufacturer response for system, hypothermia, intravenous, cooling, start-up kit custom luer (per site reporter).Not known.

• Brand Name: START-UP KIT CUSTOM LUER
• Common Device Name: SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave; san jose CA 95131
• MDR Report Key: 20199121
• Report Number: 20199121
• Device Sequence Number: 6674854
• Product Code: NCX
• UDI-Device Identifier: 00849111075336
• UDI-Public: (01)00849111075336
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/22/2024
• Report Date (Section F): 08/22/2024

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
• Device Model Number: CG-500D
• Device Catalogue Number: 8700-0784-01
• Device Lot Number: 185568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 08/22/2024