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

Model Number	DI-300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The samples were received in used conditions and without their original packaging.A bag with a solution of blue ink/water was connected to the samples, in order to verify for leaks.The sample 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 leak paths in the bonding between the spike and the drip chamber and no discrepancies were detected.Corrective and preventive action (capa) was initiated to determine the root cause and implement corrective actions.The root cause of the reported issue was found to be related to manufacturing.Actions were taken to mitigate the reported issue: production personnel was retrained on the manufacturing procedure by the production supervisor to reinforce the bonding operation between the drip chamber and the spike.The leak test of the drip chamber and spike assembly was also reinforced.
Event or Problem Description
It was reported that when set was put under pressure there was a leak.No patient injury was reported.

• 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; beckett st; minneapolis, MN 55442
• MDR Report Key: 15656426
• Report Number: 3012307300-2022-25945
• Device Sequence Number: 14944079
• Product Code: LGZ
• UDI-Device Identifier: 20695085430015
• UDI-Public: 20695085430015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2022

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 Model Number: DI-300
• Device Catalogue Number: DI-300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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