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

Model Number L-370

Device Problems Difficult to Insert (1316); Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

Event Description

Additional information received on 09-dec-2022 via email: disregard this issue.We found out from our biomed department that i guess you need to make sure to push in the line all the way and it is very difficult.

Manufacturer Narrative

Event problem and evaluation codes: updated additional event information received (updated b5) 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.

Manufacturer Narrative

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.

Manufacturer Narrative

H6: health impact and evaluation codes: updated this remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 HOTLINE DISPOSABLES
• Type of Device: 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: 15828826
• MDR Text Key: 307577810
• Report Number: 3012307300-2022-27334
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1