MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Failure to Sense (1559); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

D5.Operator of device is unknown, no information has been provided to date.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there were sensor errors.Patient involvement unknown.

Manufacturer Narrative

Investigation summary: the affected device was received for evaluation.The device had no physical damage.After visual inspection, the reservoir was filled with water, the temp check e5581 was attached, the line cord was plugged in, and the power turned on for functional testing.The customer's indicated failure could not be duplicated or confirmed, and the root cause could not be determined.As a result, no action was taken.The manufacturing dhr review found no indication that the manufacturing issue.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18564508
• MDR Text Key: 333494571
• Report Number: 2183161-2024-00098
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1