MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the level 1 hotline low flow system exhibited an unspecified product problem.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system (hl 390) was returned for investigation in excellent condition.The reason for the product return was not provided.Visual inspection did not reveal any damage on the device.Following the visual inspection, the investigator filled the tank with water, plugged in the line cord, and turned on the power switch.The investigator noted the device exhibited a safety/electrical test failure due to a loose ground stud.The problem source of the reported product problem was unknown.A root cause was not established.The ground stud was tightened.This measure corrected the product problem.Preventative maintenance was then performed, after which, the device passed all the functional tests.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9960550
• MDR Text Key: 187690672
• Report Number: 3012307300-2020-03142
• 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
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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
• Device Operator: No Information
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1