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

Catalog Number CON-HL-90

Device Problem Mechanical Problem (1384)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.A visual inspection of the returned device found a cracked tank cover, faded line cord, and an outdated printed circuit board (pcb) and power switch.Functional testing was performed by filling the tank with water, attaching the temperature check, plugging in the line cord, and turning on the power switch.The reported problem was confirmed, the disposable alarm sounded right away and the water was not circulating.The reported problem was caused by a damaged micro switch which caused sounding of both alarms and caused inactivation of the pump.No repair actions were taken.Due to the age and condition of the unit, it was scrapped.A device history record (dhr) review was not performed because the results of the complaint investigation did 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.Udi number, operator of device, and initial reporter sent report to fda are unknown.No product information has been provided to date.

Event Description

It was reported that the device was giving alarms.The circulating was not working properly.No additional information available.No patient injury was reported.

Manufacturer Narrative

Additional info received via email 24-jun-2022.Event date was updated to (b)(6) 2022.No patient involvement was reported.User checked out and found flashing red indicator with audible alarm.Not enough circulating water.

• 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: 14684012
• MDR Text Key: 293917447
• Report Number: 3012307300-2022-11769
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1