MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID

Catalog Number	H-1129
Medical Device Problem Codes	Break (1069); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fluid drain valve was broken at bottom of unit.There was no reported patient involvement.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
D9: 25-oct-2025.H3: one device was returned with the allegation that the valve was not draining.The returned device was inspected the customer reported issue was confirmed.The valve was clogged, causing the drainage issue.The blockage in the valve was cleared, restoring proper drainage, and the issue was resolved.The unit passed all testing criteria after the repair.

• Brand Name: LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23003825
• Report Number: 3012307300-2025-10414
• Device Sequence Number: 9413570
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: (01)50695085812904(11)201202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: Other
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown