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

Catalog Number	H-1129
Medical Device Problem Codes	Defective Alarm (1014); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.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.
Event or Problem Description
It was reported that the device was not re-circulating the fluids and the alarms were not working.The event occurred during testing and no patient involved.
Additional Manufacturer Narrative
One device was received for investigation.The device was visually inspected and functionally tested.The reported problem was duplicated.The device enters operation mode, but the pump and heaters do not activate.The root cause is a faulty pcb.This was replaced and the device passed all functional tests.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 SYSTEM
• 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: 19472694
• Report Number: 3012307300-2024-04571
• Device Sequence Number: 7424074
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: (01)50695085812904(11)160831
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2016
• 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