MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 FLUID WARMER IV SET; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number	D-100---802
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by rn that level 1 rapid infuser was used to administer warmed blood products rapidly for a cat 1 trauma patient.During setup of the equipment the blood started to leak from the filter section of the tubing which caused leakage onto the floor.There was patient involvement with no harm.
Additional Manufacturer Narrative
H10: mw5186267.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 FLUID WARMER IV SET
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25201066
• Report Number: 3012307300-2026-05090
• Device Sequence Number: 8889514
• Product Code: KZL
• UDI-Device Identifier: 40695085410004
• UDI-Public: (01)40695085410004(17)300104(10)6162700
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: D-100---802
• Device Lot Number: 6162700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White