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

Model Number L-70NI

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of medical fluid from the blue connector was observed.No patient injury was reported.No additional information is available for this complaint was reported.

Manufacturer Narrative

Date of eventb3: 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 additional reportable information becomes available.

Manufacturer Narrative

H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Two (2) photos were provided and reviewed as part of the device analysis.Photo one showed a hotline warming set next to its original packaging label; the complete device is observed, but no damage or dysfunctional conditions are observed.Photo two showed a close-up of the distal end where a fluid leak was observed in the hl swivel return connector and the 3-lumen tube join.One product was received with its original packaging, in used condition, and decontaminated inside a zip-lock bag.The product was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination and was observed to present delamination in the distal end hl swivel return connector and 3 lumen tube join.To verify if leakage can be confirmed, which can be caused by a lack of solvent detected previously in visual inspection, a leak test was performed.The product failed the leak test confirming the complaint.Based on the analysis on the returned product, and review of the mitigations during the manufacturing process, the root cause was lack of solvent caused improper following of procedures.A device history record (dhr) review showed no discrepancies or nonconformance's during the manufacturing of the reported lot number.Awareness notification was made to production personnel to explain the importance of adhering to, and following, procedure.

• 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: 16595007
• MDR Text Key: 311821842
• Report Number: 3012307300-2023-02929
• 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: 05/31/2023

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
• Device Operator: Health Professional
• Device Model Number: L-70NI
• Device Catalogue Number: L-70NI
• Device Lot Number: 4297598
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1