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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

It was reported that there was a malfunctioning float switch.

Manufacturer Narrative

Other, other text: manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.Visual and functional testing were performed.Visual inspection found a cracked tank cover, corroded drain fitting, broken led's on printed circuit board (pcb), faded line cord and damaged front cover.Functional testing found the flow switch operated as intended.Device passed all functional testing, unable to replicate the reported issue.No problem found.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.

Event Description

Additional information was received which included the event date and there was no patient involvement.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Product sample was received for evaluation.Visual and functional testing were performed.Physical observation showed cracked tank cover, corroded drain fitting., broken light-emitting diode (led) on printed circuit board (pcb), faded line cord, and damaged front cover.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord and turned on the power switch.The customer reported problem was not duplicated.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: replaced pcb, drain fitting, front cover, tank cover, and line cord.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

Event Description

Additional information: no patient involvement.

• 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): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13518576
• MDR Text Key: 285822751
• Report Number: 3012307300-2022-03281
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1