MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM CHEST DRAINS

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no lot number, or sample was provided.Per the article, at of shed whole blood from hemothorax is a safe and effective practice in severely injured trauma patients.Autologous shed whole blood transfusion significantly reduced blood product requirement and overall hospital costs.Concerns regarding the complications associated with autologous shed whole blood transfusions did not equate to causing clinically relevant complications, and this practice can be safely implemented in trauma and acute care setting.

Event Description

Received an article titled: "early autologous fresh whole blood transfusion leads to less allogeneic transfusions and is safe" from the division of trauma, critical care, burns and emergency surgery of university of arizona in 2014.The study consisted of a multi-institutional retrospective study of all trauma patients who received autologous whole blood transfusion from hemothorax from two level i trauma centers.Patients who received autotransfusion (at) were matched to patients who did not receive at (no-at).Some of the chest tube collection devices and their blood collection bags used in autotransfusion were atrium devices.The study involved 136 patients with ats were matched with 136 similar patients who received allogeneic transfusions only, giving a total of 272 patients.Per the study, patients on at and non-at had in-hospital complications, however the author did not relate the complications to the atrium devices used.

• Brand Name: ATRIUM CHEST DRAINS
• Type of Device: ATRIUM CHEST DRAINS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5588193
• MDR Text Key: 43156861
• Report Number: 1219977-2016-00065
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/20/2016
• 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