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

Model Number	L-370
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device serial number/lot number is unknown, no product information has been provided to date.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 the customer was having issues with the connection not being completely connected.The unit was leaking fluid due to the new tubing.This has been happening often with the new system.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other text: b5: additional information.H6: event problem and evaluation codes: updates not required.H10: 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.
Event or Problem Description
Additional information received on 09-dec-2022 via email and attached to complaint object: the customer reported that we need to disregard this issue.They found from the technical department that they need to make sure to push in the line all the way and this was very difficult to do.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.No lot or serial numbers were communicated; d4: device expiration date and h4: device manufacturing date are not available.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 HOTLINE DISPOSABLES
• Common Device Name: 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: 15829304
• Report Number: 3012307300-2022-27337
• Device Sequence Number: 12300927
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2023

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: L-370
• Device Catalogue Number: L-370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/21/2022; 05/09/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/31/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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