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

Model Number HL-390

Device Problems Insufficient Heating (1287); Failure to Pump (1502)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was received for evaluation and a visual inspection was performed.It had a faulty pump, corroded drain fitting, and rusty heater.The tank was filled with water, a temp check was attached, the line cord was plugged in, and the power turned on for functional testing.A temp check, digital thermometer, and the lcd read a low temperature and the pump was not circulating any water, confirming the customer's indicated failure.The root cause was the faulty pump, and whatever fluid was used in circulation rusted the inside of the heater, which damaged much of the circulating water system.As a result, the pump and heater were replaced, along with the pump assembly, drain fitting, heater assembly, and pole clamp.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 Description

It was reported that the temperature was low, and the pump was not working or recirculating water during testing.No issue related to physical damage or mishandling.There was no patient involvement and no harm/adverse event reported.

• Brand Name: LEVEL 1 LOW FLOW CONSIGNED HOTLINE FLUID WARMER
• Type of Device: 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: 19075591
• MDR Text Key: 339776909
• Report Number: 3012307300-2024-02305
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)190918
• 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: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Other
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1