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

Model Number HL-390

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5.Operator of device is unknown, no information has been provided to date.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 the fluid warming device leaked.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

H6 - updated one device was received for investigation.The device was visually inspected and functionally tested.The reported complaint was confirmed.The device was leaking on the bottom of the water tank cover.The water tank cover was replaced.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• 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: 18660393
• MDR Text Key: 334786264
• Report Number: 2183161-2024-00126
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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