MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi#: no udi number.

Event Description

It was reported the device shows (-1) no matter what the temperature is.No patient injury was reported.

Event Description

Additional information was received that the event occurred during testing and there was no patient involvement.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: codes updated.One fluid warmer device was received for investigation.A visual inspection identified damage to the unit drain tube.A functional test replicated the reported temperature reading problem, confirming the customer complaint.The issue was traced to the unit printed circuit board (pcb), which was determined to be faulty.No root cause could be identified for the pcb failure.A review of the device's service record did not find any reports of this issue within a year of the unit's date of manufacture, therefore a manufacturing-related root cause was ruled out, and a manufacturing device history record was not deemed necessary.As the unit is no longer needed in service, the device was decommissioned.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 16070266
• MDR Text Key: 308268586
• Report Number: 3012307300-2022-28284
• Device Sequence Number: 1
• Product Code: LGZ
• 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,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1