MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used hotline warming set-disp was returned for evaluation.Upon visual inspection, a hairline cracks were observed on the upstream luer of the infusate fluid path.Upon functional testing, an attempt to prime the infusate line was done using an icu medical provided syringe.A leak was observed originating from the crack on the infusate line luer.The complaint of leakage can be confirmed.The probable cause is due to unintended external forces on the luer.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Date of event: since the exact event date was unknown in december, it was updated as first day of december.
Event or Problem Description
It was found during investigation of the returned device that a hairline crack and leak was found on the on the infusate line luer.There was patient involvement, but no patient harm.This report captures the second of two occurrences.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
• 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: 24522421
• Report Number: 3012307300-2026-02110
• Device Sequence Number: 18271372
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)270127(10)4364734
• 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): 03/05/2026

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-70
• Device Lot Number: 4364734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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