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

Model Number	HL-90-38
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was received for evaluation.The enclosure was cracked, the water tank was stained, the reservoir gasket was worn, the line cord was faded, and the drain fitting, pcb, and power switch were outdated.After visual inspection, the reservoir was filled with water, the temp check e5579 was attached, the line cord was plugged in, and the power turned on for functional testing.The customer's indicated failure was confirmed as the over temp alarm went off at the incorrect temperature.The faulty pcb was the root cause.No action was taken due to the condition and age of the device.It was deemed beyond economical repair and will be scrapped.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the device needed attention for the receiving dock.There was unknown patient involvement and unknown patient harm/adverse event reported.

• Brand Name: LEVEL 1 LOW FLOW - CONSIGNED 38 DEGREE HOTLINE FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18981700
• Report Number: 3012307300-2024-01677
• Device Sequence Number: 6280010
• Product Code: LGZ
• UDI-Device Identifier: 50695085002404
• UDI-Public: (01)50695085002404(11)081022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/26/2024

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: Other
• Device Model Number: HL-90-38
• Device Catalogue Number: CON-HL-90-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2008
• 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