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

Model Number H1129

Device Problems No Flow (2991); Excessive Heating (4030)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical level 1® normoflo® irrigating system was observed to run overtemperature and that the flow then stopped.There were no reported adverse effects.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was given functional testing; this showed a crack in the return tube which allowed for water to leak from the warming tank.The cause of the cracking was not confirmed.

• Brand Name: LEVEL 1 NORMOFLO IRRIGATING SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9566074
• MDR Text Key: 176666526
• Report Number: 3012307300-2020-00246
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H1129
• Device Catalogue Number: CON-H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1