MAUDE Adverse Event Report: ATRIUM MEDICAL OASIS DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Air Leak (1008)

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

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that an oasis drain had an air leakage.

Manufacturer Narrative

Based on the details of the complaint and correspondence with the institution the drain line had a leak prior to the connection.The details do not indicate what connection exactly and attempts to obtain further details have not been answered.The details provided state ¿the multidisciplinary team was gripping the entire length of the drain hose, until it felt an air leak near the connection, evidencing a hole¿.Without the drain in question atrium cannot confirm that there was a leak in the patient line and not within the connection to the chest tube.The details also indicate that the drain line was clamped and the leaking stopped.This information would indicate that there was a leak further up the line possibly where the catheter was attached to the drain line.Clinical evaluation: atrium chest drains are indicated to evacuate air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there was a loose connection between the patient and the drain.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.The instructions for use (ifu) states patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.

• Brand Name: OASIS DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7495604
• MDR Text Key: 107635768
• Report Number: 3011175548-2018-00462
• Device Sequence Number: 1
• Product Code: CAC
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 248568
• Other Device ID Number: 00650862110012
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 80