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

Model Number	D-300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device tubing leaked on setup.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The samples had a leak in the bonding between the drip chamber and the spike.During review of manufacturing process, a sample of 32 units was taken to perform a visual inspection to verify for voids, dents, holes or cracks in the assembly or components and no discrepancies were detected.The root cause of the reported issue was not determined with the provided information.Action taken to mitigate the reported issue: a corrective and preventative action has been opened to address the reported issue.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING SET
• Common Device Name: 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: 15656351
• Report Number: 3012307300-2022-25926
• Device Sequence Number: 11395487
• Product Code: LGZ
• UDI-Device Identifier: 20695085430008
• UDI-Public: 20695085430008
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: D-300
• Device Catalogue Number: D-300
• Device Lot Number: 3565274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown