MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used device was received for evaluation.Functional and visual tests were done; the reported issue can be duplicated.The root cause of the issue was due to an assembly error where the vent was incorrectly adhered to the gas vent body.A review of the device history record (dhr) indicated that all inspections were completed during manufacture, and no issues had been noted at that time.This file was originally incorrectly filed under registration number mrn 9617604-2025-00261.The date of that submission was 10-nov-2025.
Event or Problem Description
It was reported that blood leaked during use.The event occurred during patient administration at the facility.No patient harm or adverse event was reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23838023
• Report Number: 3012307300-2025-13599
• Device Sequence Number: 9268232
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: (01)40695085401002(17)281024(10)6062903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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 Catalogue Number: L-10
• Device Lot Number: 6062903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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 Sex: Unknown