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

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

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 ocean chest drain has to the reported adverse events.The article concluded the digital thoracic drainage systems provide an objective measurement of air leakage, allowing early chest tube removal and decreasing the number of radiographs performed postoperatively.Its use in the pediatric population appears to be safe and potentially beneficial.Based on the information available atrium has determined that the events described are not related to a product failure.

Event Description

Received an article titled digital thoracic drainage: a new system to monitor air leaks in pediatric population.Purpose: the objective of our study is to analyze their safety and effectiveness in the postoperative period of the pediatric patients.Method: a prospective consecutive observational study was done.All patients submitted to pulmonary resection between 2011 and 2017 and in whom digital thoracic drainage system was used were prospectively enrolled in this study.Per the article adverse events included: persistent air leakage requiring blood pleurodesis.

• Brand Name: OCEAN 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: 10000776
• MDR Text Key: 190478748
• Report Number: 3011175548-2020-00583
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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: 04/22/2020
• 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