MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE 290 FLUID WARMING DEVICE; WARMER, THERMAL, INFUSION FLUID

Model Number HL-290

Device Problems Insufficient Heating (1287); Mechanical Problem (1384)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported the device "broke down".No adverse effects reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.Visual and functional testing were performed.The device was unpacked, the tank was filled with water and the disposable was attached.But after the start button was pressed audio alarm came one and the device didn't work.After opening the device was discovered that the water sensor assembly was defective.The root cause of the reported issue was found to be a defective water sensor assembly.Actions were taken to mitigate the reported issue: the water sensor assembly, pump and safety and valve solenoid were replaced.

• Brand Name: LEVEL 1 HOTLINE 290 FLUID WARMING DEVICE
• 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 n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 13019379
• MDR Text Key: 282346248
• Report Number: 3012307300-2021-12701
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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-290
• Device Catalogue Number: HL-290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1