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

Catalog Number CON-HL-390

Device Problem Power Problem (3010)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline low flow system was received with a cracked tank cover.There was wear and tear damage on the enclosure, line cord, block assembly and front cover.The printed circuit board (pcb) and power switch were outdated.The line cord was plugged into a power source, but there was no power.The front cover and pcb were removed to inspect the power switch to the pcb connection.The reported issue was able to be duplicated.The power switch to pcb connection was damaged due to daily use turning the power on and off.No action was taken to repair the device due to the age and condition of the device.

Event Description

Information was received indicating that a smiths medical level 1 hotline low flow system had no power.There was no reported adverse event.

• 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 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11304240
• MDR Text Key: 231109717
• Report Number: 3012307300-2021-01089
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/09/2021

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: Health Professional
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2011
• 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