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

Model Number	L-270
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device connection was broken.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).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 sample port is broken.The leak tester fail the test and an alarm was activated.It is unlikely that the damage was caused in the manufacturing process; the most probable cause is that the damage was caused after the product left manufacturing facilities.The root cause of the reported issue was unable to be determined.Actions were taken to mitigate the reported issue: no corrective actions are required since it's unlikely that needle was bent during the manufacturing process.

• 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: 15656336
• Report Number: 3012307300-2022-25921
• Device Sequence Number: 2530248
• Product Code: LGZ
• UDI-Device Identifier: 30695085402705
• UDI-Public: 30695085402705
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K001764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• 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: 12/13/2021
• Device Model Number: L-270
• Device Catalogue Number: L-270
• Device Lot Number: 3546412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown