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

Model Number HL-90

Device Problems Break (1069); Device Damaged Prior to Use (2284); Pumping Problem (3016)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

One warmer device was received for investigation.During visual inspection the device was observed to have broken led's (light emitting diodes), corroded drain fitting, cracked tank cover, bent micro switch, worn plate clip, and damaged front cover.The reported issue was confirmed during functional testing when the warmer circulation produced by the device was intermittent and the led's on the circuit board were damaged confirming the customer complaint.The investigation traced the circulation issue to damage to the device microswitch.The investigation traced the led issue to a misaligning of the top cover, causing damage to the led's.The investigation attributed the root cause of these issues to the bent micro switch which activates the pump and the led's were damaged by the front cover being forced on the device.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service previously.The warmer circuit board, drain fitting, tank cover, plate clip, micro switch, and front cover were all replaced.Preventative maintenance was performed.

Event Description

It was reported that the warmer had broken led's and water will not circulate.The event occurred during testing on (b)(6) 2022.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): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 840 s wood st blg 920 rm b29; minneapolis, MN 55442
• MDR Report Key: 16546674
• MDR Text Key: 311346833
• Report Number: 3012307300-2023-02482
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1