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

One smiths medical level 1 hotline low flow system was returned for analysis with a wear and tear damaged enclosure and faulty pump assembly.During analysis, the reported issue was able to be duplicated.It was noted that the pump assembly was faulty and didn't pump water as it should and was the cause of the reported issue.Service replaced the pump assembly to correct the reported issue.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be faulty pump.

Event Description

Information was received indicating that a smiths medical level 1 hotline low flow system was not working.It was not specified whether this occurred during infusion or interrupted therapy.No adverse effects were reported.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10057545
• MDR Text Key: 190983584
• Report Number: 3012307300-2020-03951
• 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: 05/14/2020

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: 08/23/2019
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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