MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1129
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical level 1 normoflo irrigation fast flow systems - h-1100 warmer required actuator repair.No adverse effects were reported.
Additional Manufacturer Narrative
Evaluation results: one level 1 normoflo irrigation fast flow system was returned for investigation in good condition with no physical damage.The device was manufactured in 2017.The investigator placed the device on top of rolling base and powered it on.The actuator pole did not go upward.The investigator then removed the rolling base bottom panel for further investigation.Visual inspection did not reveal any damaged components.The investigator then installed an actuator pole as a standard test for the rolling base.The actual pole did not move upward and downward after pressing the membrane switch.The customer reported product problem was therefore confirmed.The problem source of the reported product problem was unknown.A root cause was not established.In addition to the above the investigator also noted an additional product problem.The insulator on heater #2 was torn, and a crack in the return tube was observed.Based on the aforementioned observations the investigator replaced the following components: actuator pole, actuator pole switch, return tube, and both heaters.The investigator then installed a temp-check test fixture.The measured temperature was 41.7c degrees which was within tolerance. the device passed all functional and electrical tests following the aforementioned repairs.
Additional Manufacturer Narrative
Additional information received by smiths medical that the issue occurred during testing and caused the device not to be used.

• Brand Name: LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9536241
• Report Number: 3012307300-2019-07480
• Device Sequence Number: 14287147
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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: No Information
• Device Model Number: H-1129
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 03/16/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 02/04/2020; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1