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

Catalog Number CON-HL-90

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.This mdr was generated under protocol (b)(4)., as a result of warning letter (b)(4).No device history review is not applicable or relevant due to the device manufactured date.The investigation did not implicate a service process issue.A product sample was received for evaluation.Functional and visual testing were performed.The device was received in good condition.The evaluation was performed, and the reported issue was confirmed.Low fluid alarm was activated.Pressed general alarm test switch and both visual and audible alarms were present.The interlock alarm test was performed and activated.Visual inspection revealed no leaks from reservoir or circulating system.Removed front cover for further investigation.Circuit board was free from damage.Device under test liquid crystal display was inaccurate.Device was recalibrated and temperature stabilized.Device operated as designed.Device was then cycled on and off and device did not power up as this was intermittent.The root cause of the reported issue was unable to be determined.No further actions were required.

Event Description

It was reported that the device was a defective unit.No patient injury was reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15640781
• MDR Text Key: 306618308
• Report Number: 3012307300-2022-25486
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1