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

Model Number HL-90

Device Problem Insufficient Heating (1287)

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

Event Type  malfunction  

Event Description

Information was received that a smiths medical level 1 hotline blood and fluid warmer was not warming.No adverse patient effects were reported.

Manufacturer Narrative

One fluid warmer was received for evaluation.Visual inspection of the device found it to be noisy, has a bent micro switch and interlock block threads stripped.The device underwent functional testing by being filled with water, and temperature subsequently checked.This test confirms the reported customer complaint as the device was not heating up.The problem source has been determined to be the faulty heater from normal wear and tear.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9192440
• MDR Text Key: 174159929
• Report Number: 3012307300-2019-01723
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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 Model Number: HL-90
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1