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

Device Problem Gas/Air Leak (2946)

Patient Problems Hemothorax (1896); Unspecified Infection (1930); Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this report as no product number, lot number or sample was provided.It is not known what relationship the oasis chest drain has to the reported adverse events the article concluded digital devices did not result in reduced chest tube duration or hospital length of stay.Based on the information available atrium has determined that the events described are not related to a product failure.Not available for return.

Event Description

Received an article titled digital air leak monitoring for lung resection patients: a randomized controlled clinical trial.Purpose: the objective of this study was to compare digital and analog devices in patients undergoing anatomic lung resection.Method: a single-institution randomized trial was conducted.Patients undergoing anatomic lung resection between november 2013 and july 2016 were randomized to digital or analog devices.Conclusion: digital devices did not result in reduced chest tube duration or hospital length of stay.Per the article adverse events included, increasing pneumothorax, subcutaneous emphysema, air leak, chest tube reinsertion, empyema and hemothorax.

• Brand Name: OASIS CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9991725
• MDR Text Key: 189625837
• Report Number: 3011175548-2020-00565
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention