MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390, 38 DEGREE; WARMER, THERMAL, INFUSION FLUID

Model Number	HL-390-38
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in with damaged printed circuit board (pcb), cracked tank cover, and corroded drain fitting.Functional testing could not duplicate the leak complaint, the device ran for several hours with a temperature check and disposable without any problems.The probable cause is a disposable or temperature check at the customer site.Replaced the pcb, drain fitting, and tank cover.Performed preventative maintenance (pm).The device passed all functional tests after repairs and pm.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.
Event or Problem Description
It was reported that the device was leaking water near the connection where you put the tubing set.The event occurred during preventive maintenance inspection in the biomed shop.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390, 38 DEGREE
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19822392
• Report Number: 3012307300-2024-06567
• Device Sequence Number: 21006342
• Product Code: LGZ
• UDI-Device Identifier: 10695085002826
• UDI-Public: (01)10695085002826(11)160502
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 07/24/2024

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-390-38
• Device Catalogue Number: CON-HL-390-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2016
• 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