MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the pump is noisy.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Udi information is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Other, other text: d10, h6: event methods, evaluation, and conclusion codes: updated.Device evaluation: one warmer device was received for investigation.During visual inspection the device was observed to have rust all over enclosure, front cover, and main block.The quick connect was corroded, pole clamp would not work, the water tank has cracks, enclosure is cracked on the top next to the water tank cap, the circuit board is missing a stand off behind the display, and the line cord has damage to the outer insulation.The reported issue was confirmed during functional testing when the warmer pump was determined to be noisy.The issue was traced to corrosion on the pump mechanism.The probable cause was attributed to the running of incorrect solution in the device; causing the pump to become rusty.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service previously.Due to the age of the device, it has been deemed beyond economical repair and will be decommissioned.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16709637
• MDR Text Key: 312986200
• Report Number: 3012307300-2023-03891
• Device Sequence Number: 1
• Product Code: LGZ
• 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,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1