MAUDE Adverse Event Report: ATRIUM MEDICAL EXPRESS DRY SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study use of post-lung resection digital drainage does not appear to decrease pleural fluid formation, but is associated with decreased prolonged air leaks.[(b)(4)].

Event Description

Received an article titled "does the usage of digital chest drainage systems reduce pleural inflammation and volume of pleural effusion following oncologic pulmonary resection".The purpose of the article was to hypothesize that digital drainage systems, using intermittent balanced suction, are associated with decreased pleural inflammation and postoperative drainage volumes, thus leading to earlier chest tube removal.Per the article post operative deaths occurred during the study.One due to respiratory compromise and one due to massive pulmonary embolus after discharge.

• Brand Name: EXPRESS DRY SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7540104
• MDR Text Key: 109113546
• Report Number: 3011175548-2018-00518
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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: 05/04/2018
• 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): Death