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

Catalog Number CON-HL-90

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

It was reported that there was over temping and water not circulating.No patient involvement was reported.

Manufacturer Narrative

One device was received and evaluated.Visual inspection found the enclosure cracked, the pole clamp broken and an outdated pcb and power switch.Functional testing was performed and confirmed the reported issues.The overtemp alarm was observed to be out of calibration and the micro switch was bent causing intermittent circulation.The root cause is underdetermined due to the age and condition of the returned device.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.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sample was received for evaluation.Visual and functional testing were performed.Cracked enclosure, broken pole clamp, outdated printed circuit board (pcb).And power switch.The technician started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The reported issue was confirmed.The root cause of the report issue was found to be the over temp alarm was out of calibration and the bent micro switch caused intermittent circulation.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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: 14101930
• MDR Text Key: 289178618
• Report Number: 3012307300-2022-06291
• 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
• Report Date: 03/15/2023

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1