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

Lot Number UNKNOWN

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 no significant difference was observed when the dcd was compared with the classic system.Based on the information available atrium has determined that the events described are not related to a product failure.Device evaluated by manufacturer? not available for return.

Event Description

Article received titled the benefits of digital chest drainage n pleural decortication in thoracic empyema.Prospective, randomised, control trial.Cirugia y cirujanos, pp.522-525.Purpose: the aim of this study is to compare the effects of prolonged air leak between the digital chest drainage (dcd) system and the classic drainage system in patients with empyema class iib or iii (american thoracic society classification) in pleural decortication patients.Method: a total of 37 patients were enrolled in a prospective randomised control trial over one year, consisting of 2 blinded groups, comparing prolonged air leak as a main outcome, the number of days until removal of chest drain, length of hospital stay and complications as secondary outcomes.Per the article adverse events included: hemothorax, atelectasis, prolonged air leak, prolonged fluid leak and residual collections.

• 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: 10001319
• MDR Text Key: 189883864
• Report Number: 3011175548-2020-00586
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Device Lot Number: UNKNOWN
• 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