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

Model Number	HL-390
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the alarm had no audio.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was 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.
Additional Manufacturer Narrative
One device was returned for analysis with complaint of no alarm audio.This device has not been serviced for the past 12 months.Visual and functional testing was performed.Performed a visual inspection, filled reservoir with water, plugged in line cord, turned on power, and performed functional tests.Complaint was verified.The device has no audio alarm, due to the faulty printed circuit board (pcb).

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL, INC; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22010008
• Report Number: 3012307300-2025-05581
• Device Sequence Number: 20806538
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)191014
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• 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
• Date Returned to Manufacturer: 05/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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