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

Catalog Number L-70NI

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

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

Event Date 07/23/2023

Event Type  malfunction  

Event Description

It was reported that there was damage to the female connector on the blood transfusion side.This was found during pre-test.

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Two (2) photos were included for evaluation; one photo shows a female luer cracked.One (1) device was received with its original packaging label, in used condition, and decontaminated inside a zip lock bag.Results from visual inspection: it was observed a crack on luer lock adapter female, complaint was confirmed.No other analysis was performed.Based on the analysis conducted the root cause was determined as supplier item fault.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The supplier was notified about the issue.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING DISPOSABLE SET
• Type of Device: 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: 17610721
• MDR Text Key: 321815002
• Report Number: 3012307300-2023-08377
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407502
• UDI-Public: 30695085407502
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L-70NI
• Device Lot Number: 4308813
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1