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

Catalog Number DI-50

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 08/07/2018

Event Type  malfunction  

Event Description

It was reported that the device tubing had kinked.No patient injury was reported.

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.No physical damage was observed.There was a kink in the tubing of the gas filter assembly.The root cause of the reported issue was found to be manufacturing.A sample of 32 units was taken from production area, in order to perform a visual inspection to verify for kinked tubing and no discrepancies were found.Actions were taken to mitigate the reported issue: production personnel was retrained by the production supervisor in order to review and reinforce the bonding operations and the packaging operation.Udi information is unknown.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING SET
• Type of Device: 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: 15656338
• MDR Text Key: 306985059
• Report Number: 3012307300-2022-25923
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2022
• Device Catalogue Number: DI-50
• Device Lot Number: 3606237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1