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

Catalog Number	H-1129
Medical Device Problem Codes	Temperature Problem (3022); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the device was inconsistent, neither increasing nor decreasing.It also makes a loud sound.The event occurred during infusion.There was no patient harm reported.
Additional Manufacturer Narrative
The device was not returned for analysis.Service history identified that no previous repair has been noted in the last 12 months.As the product was not returned, and no photographic evidence was provided to aid in this investigation, a product evaluation and problem confirmation cannot be performed.Therefore, this investigation was unable to determine a probable cause.
Additional Manufacturer Narrative
Received one device.Visual inspection found no damage related to customer concern.The reported complaint could not be confirmed as described.The power pole operated consistently, and the clicking noise at the end of the raising/lowering cycle appears to be inherent to the mechanism¿s normal function.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21942156
• Report Number: 3012307300-2025-05094
• Device Sequence Number: 8382191
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: (01)50695085812904(11)240227
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: Health Professional
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 11/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/15/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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