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

Catalog Number CON-HL-90

Device Problems Power Problem (3010); Pumping Problem (3016)

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

Event Date 05/17/2019

Event Type  malfunction  

Event Description

It was reported that there was no power.We use the hydrogen peroxide/distilled water maintenance solution.Fluid was replaced and all tests had been completed when prior to turning the unit off and returning it to service, the pump stopped.We cycled the power and attempted to restart the pump but were unsuccessful.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).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.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.Visual inspection found the device was in fair condition with scrapped paint.During the power up process, the reported complaint was confirmed.The root cause of the reported issue was found to be broken connection between main board and power switch.This is a known design issue.Replaced main board and power switch.Power up process and device passed all the functional testing.A corrective and preventative action has been opened to address the reported issue.(udi) is unknown.No product information has been provided to date.

• 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; 200 jefferson st se clinical e; minneapolis, MN 55442
• MDR Report Key: 15637570
• MDR Text Key: 306994745
• Report Number: 3012307300-2022-25298
• 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
• Report Date: 10/20/2022

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1