MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this report a follow up report will be submitted.

Event Description

Customer reports kinking of tubing in packaging.Once tubing has been removed a kink remains due to time of tubing in packaging.

Manufacturer Narrative

Analysis: the oasis chest drains in question were evaluated to determine the cause of the complaint.Upon review of the returned tube sets there was one kink in the same location on every tubing set evaluated.To determine if the kink in the tubing prohibited flow each tubing set was tested per test procedure.The test procedure was created and derived based on the requirements set forth in iso standard bs en iso 10079-3 2014.The results of this testing indicate that even with the kink in the tubing the airflow met the procedural requirements of 7.5 slpm.The lowest value seen was 27.5 slpm.This far exceeds the procedural requirement.To date there have been no other complaints from around the world.Except from the two institutions in australia.There have been over (b)(4) produced since this change was implemented in february of 2019.Summary/conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the patient tube set kinking creates a patient risk.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8809788
• MDR Text Key: 151774393
• Report Number: 3011175548-2019-00778
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention