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	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood leaked from the connection between the hotline heating tube and the hotline main unit during priming.There were no patient involvement and no patient harm.
Additional Manufacturer Narrative
B3: date of event unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• 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.; avenida calidad no.4; parque indus international; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25739115
• Report Number: 3012307300-2026-07138
• Device Sequence Number: 18756675
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: Other
• Device Catalogue Number: L-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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