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

Model Number 3612-100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

The chest drain was set up.After three hours it was noted that the water seal chamber, that had appropriate fluid level, was almost empty.The fluid was replaced and 3 hours later the water seal chamber was once again empty.The drain was replaced with a new drain which functioned appropriately.There were no patient affects reported.

Event Description

N/a.

Manufacturer Narrative

As the lot number was not provided a review of the device history records could not be performed.Atrium medical corporation only releases product that has met all quality and performance requirements.Based on the results of the investigation we cannot confirm that the fluid loss in the water seal was due to the actual drain.Without the actual oasis chest drain used atrium medical corporation cannot determine how the fluid was lost.Clinical evaluation - 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.The instructions for use (ifu) instruct that the suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2o or greater and that patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.

• 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: 9217804
• MDR Text Key: 168855629
• Report Number: 3011175548-2019-01112
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• 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,health
• 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: 3612-100
• Device Catalogue Number: 3612-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR