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

Model Number HL-390

Device Problems No Audible Alarm (1019); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the warmer was leaking internally.Additionally, the high temperature alarm was not sounding when the button pressed.The issue was discovered during preventative maintenance.

Manufacturer Narrative

Date of event.No information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Event methods, evaluation, and conclusion codes: updated.One fluid warmer device was received for investigation.The reported issue with the high temperature alarm was confirmed during functional testing.However the reported internal leaking could not be reproduced.The alarm issue was attributed to a fault in the device's printed circuit board.However, as device is beyond a year from its manufacture date of 2016-09-26 and there was no indication of a manufacturing defect during the investigation, no review of device history records was conducted.A review of service history indicated the device had not been serviced in the previous year, but the circuit board had been replaced during a service conducted in 2020.The device circuit board, reservoir gasket and auxiliary outlet label were replaced.The pump elbow was re-glued, and preventative maintenance was performed.

• Brand Name: LEVEL 1LEVEL 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; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16287484
• MDR Text Key: 308743263
• Report Number: 3012307300-2023-00833
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1