MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE LOW FLOW SYSTEMS HL390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the device would not power on.No adverse effects reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Additional information provided for d4, g4, h3, h6, and h10.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.No previous service history was found.Visual and functional testing were performed.The device was received with a cracked tank cover.Wear and tear damaged enclosure and line cord.Broken power switch.The technician filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The cause of the reported issue was due to a connection between the power switch and printed circuit board (pcb) has been damaged.The root cause was due to the daily use of the power switch reflected the poor design.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS HL390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 13068940
• MDR Text Key: 282700384
• Report Number: 3012307300-2021-13096
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1