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

Model Number HL-90

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the device was too loud.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.Investigation summary: the affected device was received for evaluation and was visually inspected to determine that it was in good physical condition, with small amounts of wear and tear on the enclosure.The device was unpacked, the tank was filled with water and a disposable was attached.The start button was pressed and right away it was noticed that the device was too loud, confirming the customer's indicated failure.The device cover was removed, and the chassis was making contact with the encloser on the bottom.This was determined to be the root cause of the issue.The chassis was rearranged from the 4 screws for the pole clamp, and it was pushed a little bit higher.After arranging it, the device was not noisy anymore.After performing the entire repair, a functional test was performed, and after calibration the temp was stable and in range.The o-rings and tank gasket were also replaced.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18759605
• MDR Text Key: 336179593
• Report Number: 2183161-2024-00162
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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