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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 that digital drainage systems can be safely applied in cardiac surgery patients.The use of the digital management system led to a decreased incidence of drainage associated complications as well as to shortened chest tube duration.Based on the information available atrium has determined that the events described are not related to a product failure.

Event Description

Article received titled reduction of drainage-associated complications in cardiac surgery with a digital drainage system: a randomized controlled trial.Purpose: the differences between an analog and a digital chest drainage system in cardiac surgery patients were investigated in a randomized controlled trial.Method: a total of 354 elective cardiac surgery patients were preoperatively randomized between september 2016 and september 2017 to either an analog or a digital chest drainage system aiming to compare drainage-associated postoperative outcome parameters.Per the article adverse events included: tamponade, thoracotomy, arrhythmia, stroke and tia.

• 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: 10000921
• MDR Text Key: 190479229
• Report Number: 3011175548-2020-00584
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• 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