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

Model Number 230

Device Problem Flare or Flash (2942)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that the plug to a smiths medical level 1® hotline® blood and fluid warmer was found to be burned at the device.There were no reported adverse effects.

Manufacturer Narrative

Device evaluation: customer stated problem can be confirmed.No function.Smoking marks visible on power cord and inlet filter jack.When opened we found fluid rests inside the power supply.We measured very low (0.04mohm) insulator resistance pe conductor.Normal value is >200mohm.Problem source is unknown.

• Brand Name: LEVEL 1® HOTLINE® BLOOD AND FLUID 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: 8323697
• MDR Text Key: 135611355
• Report Number: 3012307300-2019-00485
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 230
• Device Catalogue Number: HL-290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1