MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number	HL-390
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event 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 or Problem Description
It was reported that the over temperature alarm sound was not working.Nothing audible, no beeping.Patient involvement was unknown.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name, manufacturing plant address, state, city, postal code, and country updated.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, the customer problem was duplicated.The device was found to not be alarming for the over temperature.During testing the overtemperature alarm on the device was not at the correct setting so it would not alarm at a certain point when expected to.After the overtemperature alarm was reset, then the heat was turned up and the device alarmed once it went over the set point.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The device passed all functional tests and performed as intended after repair.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel aleman km 21.; 7, parque industrial; monterrey, apodaca MN 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22029965
• Report Number: 3012307300-2025-05747
• Device Sequence Number: 8151593
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)160316
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown