MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NORMOFLO® FLUID WARMING DEVICE, IRRIGATING SYSTEM; WARMER, THERMAL, INFUSION FLUID

Catalog Number	H-1129
Medical Device Problem Codes	No Audible Alarm (1019); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical irrigation fast flow fluid warmer level 1 device had no flow, and no alarm failure.
Additional Manufacturer Narrative
One fluid warmer was returned for evaluation.Upon powering on the device, it was not heating, and no water was flowing.A crack in the return tube was noted, but no residual fluid damage was found on pcb components.Installed known good pcb and powered on the device.The device powered as intended.The customer complaint has been confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: NORMOFLO® FLUID WARMING DEVICE, IRRIGATING SYSTEM
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8278526
• Report Number: 3012307300-2019-00417
• Device Sequence Number: 11105232
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/12/2019

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 Catalogue Number: H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1