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	Unexpected Shutdown (4019); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the system shut off, while running.And could not be turned back on.The on/off buttons are not working properly.There was unknown, patient involvement.And unknown, patient harm/adverse event reported.
Additional Manufacturer Narrative
E1.: initial reporter phone: (b)(6).B3: date of event is unknown.No information has been provided to date.H3: device not returned to manufacturer.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 reportable information becomes available.
Additional Manufacturer Narrative
Additional information was received stating there was no patient involvement.The following fields have been updated.A1, a2, a4, a5, a6, b5 and h6 - health effect, impact.
Event or Problem Description
Additional information was received via email informing that the event occurred during testing (prior to use) outside of patient care area.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: 10-jan-2025.H3: one device was received for investigation.The reported issue was confirmed during functional testing, when the device power switch did not function as intended.The investigation traced the issue to the device membrane switch, which was determined to be faulty.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The membrane switch was replaced, and the device functioned as intended.

• 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: 20853956
• Report Number: 3012307300-2024-14430
• Device Sequence Number: 12962014
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: (01)50695085812904(11)210304
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/14/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/10/2024; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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