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

Catalog Number CON-HL-90

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that the level sensor of a smiths medical level 1® hotline® warmer was reported to be bad.It was observed to be saying "no water" when there was water.There were no reported adverse effects.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system (hl-90) was returned for investigation in used condition.The device was received with scratches to the cover, and some discoloration was observed on the tank.The device was manufactured in 2008.The investigator powered on the unit and it alarmed check disposable.The investigator then moved the switch into a normally closed position and powered on the device again.The alarm activated when it should not have.The investigator removed the cover for further inspection.The investigator subsequently measured the open circuit in both normally open and normally closed states.This revealed that the float switch was faulty.The investigator then installed a known good test switch and performed a functional check.The disposable alarm then functioned as designed.The device was scrapped due to age however.

• Brand Name: LEVEL 1® HOTLINE® 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: 8672068
• MDR Text Key: 147101938
• Report Number: 3012307300-2019-03253
• 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: 11/20/2019

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1