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 Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
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
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during massive blood transfusion, a crack was noted at the level 1 tubing y bifurcation that allowed blood to leak and necessitated tubing replacement.There was a patient involvement and unknown patient harm reported.
Additional Manufacturer Narrative
D3: mfg.Establishment name updated.H3: no device or device photo was returned for investigation.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.If the product is returned, this complaint will be reopened for further investigation.

• 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 north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 23360640
• Report Number: 3012307300-2025-11703
• Device Sequence Number: 15671457
• Product Code: KZL
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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: 6108627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 08/07/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/24/2025; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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