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

Model Number HL-390

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.The investigator noted that there was wear and tear damage on the following components: enclosure, front cover, line cord, and a cracked water tank.The unit was also missing a reflux plug.The unit had an old style pcb and power switch.In addition, the block assembly was leaking.The tank was filled with water, a temp-check was attached, and the line cord was plugged in.The power switch was then turned on.The customer reported product problem was confirmed during testing.The device leaked from bottom of tank cover.The following components were replaced: enclosure, tank cover, line cord, reflux plug, and block assembly.The pcb and power switch were also upgraded.The problem source of the reported product problem was unknown.A root cause was not established.

Event Description

It was reported that the device was leaking from the bottom.No patient injury or complications were reported in relation to this event.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9881002
• MDR Text Key: 184997444
• Report Number: 3012307300-2020-02343
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 10/23/2019
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1