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

Catalog Number	L-370
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: investigation 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.
Event or Problem Description
It was reported that during a bench test, there were air bubbles noted in the tubing.There was no patient injury.Device pulled from use.Event reported as "still on going".
Additional Manufacturer Narrative
One unit was received without the original package, in used condition.The sample was visually inspected and there was no evidence of delamination, damage or any discrepancies that could cause the failure mode reported.The sample was tested using a syringe to replicate the failure mode.The root cause could not be determined from this analysis.The instructions for use states remove all air from the hotline fluid warming set, l-10, pc-8, and yc-8 before connecting to the patient.Failure to do so, may result in introduction of air to the patient.The failure mode will continue to be monitored and if a trend is identified an investigation will be opened.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: LEVEL 1 HOTLINE LOW FLOW DISPOSABLE WARMING SET
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18039381
• Report Number: 3012307300-2023-10050
• Device Sequence Number: 8171687
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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 Catalogue Number: L-370
• Device Lot Number: 4339666
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2022
• 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