MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY DUAL W/AC; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation into this event is completed.Device not returned.

Event Description

Received report of the middle chamber fills up before the right and left fill up.This makes it difficult to measure a leak from one chamber to the middle.

Manufacturer Narrative

The oasis drain was not returned for analysis therefore unable to confirm the complaint.The details indicate the second of three chambers was filling up prior to the first chamber.The oasis dual chest drain has two patient lines, one for air and one for fluid.Both can also be used for fluid.It is possible that the fluid was going directly into chamber two as the patient line is directly over the second chamber.This would also be the case if the patient line on the right side of the drain that is situated over chamber one was clamped off during use.There is also a possibility that the chest drain was knocked over during use.Every drain that is produced is 100% pressure tested in manufacturing to ensure there are no leaks.Summary/conclusion - based on the results of the investigation we cannot confirm that the oasis chest drain had a leak between the chambers.Clinical evaluation - chest tube insertion is performed for pneumothorax, hemothorax, pleural effusions, or empyema.In most patients, a chest tube can be easily placed with a combination of local analgesia and light conscious sedation.Problems may include slippage of the tube out of position or mechanical problems related to the drainage system.The oasis chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.The middle chamber of a traditional chest drainage system is the water seal.The main purpose of the water seal is to allow air to exit from the pleural space on exhalation and prevent air from entering the pleural cavity or mediastinum on inhalation.When the water seal chamber is filled with sterile fluid up to the 2 cm line, a 2 cm water seal is established.To maintain an effective seal, it is important to keep the chest drainage unit upright at all times and to monitor the water level in the water seal to check for evaporation.Bubbling in the water seal chamber indicates an air leak.During spontaneous respirations, the water level should rise during inhalation and fall during exhalation.If the patient is receiving positive pressure ventilation, the oscillation will be just the opposite ¿ the water level should fall with inhalation and rise with exhalation.This oscillation is called tidaling and is one indicator of a patent pleural chest tube.Fluid may leak from one chamber to another if the unit is not kept in the upright position or if the device is cracked or damaged.The instructions for use (ifu) states to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity.

Event Description

N/a.

• Brand Name: OASIS DRY DUAL W/AC
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9221633
• MDR Text Key: 168778813
• Report Number: 3011175548-2019-01128
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1