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

Model Number	HL-390
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that alarms besides the basic test alarm are producing noise or light changes when triggered.However, per reporter, the pump does stop.The issue was discovered during testing.There was no patient involvement.
Additional Manufacturer Narrative
H3: one device was returned for analysis in used condition.Visual inspection showed the front cover and j-clip were damaged.Functional testing was performed and the reported issue was confirmed.The motor was shutting off, but the alarm buzzer and leds did not function.The probable cause of this issue was a defective/worn printed circuit board (pcb).The pcb was replaced.Upon further investigation it was found that the over temperature alarm button didn't function.The membrane switch was replaced to address this issue.The device then passed all testing.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22096307
• Report Number: 3012307300-2025-06269
• Device Sequence Number: 17879501
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)180724
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/23/2025

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 Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• 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