MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number 8002910

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that the air detector clamp to a smiths medical level 1® h-1200 fast flow fluid warmer was reported to not be opening.This occurred where you would place the tubing.There were no reported adverse effects.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The testing of the returned device showed the air detector latch was stuck causing the alarm condition.The cause of the stuck latch could not be confirmed.

• Brand Name: LEVEL 1 H-1200 FAST FLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9613565
• MDR Text Key: 175868911
• Report Number: 3012307300-2020-00316
• 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: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8002910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1