MAUDE Adverse Event Report: ATRIUM MEDICAL; APPARATUS, AUTOTRANSFUSION

Device Problem Insufficient Information (3190)

Patient Problems Adult Respiratory Distress Syndrome (1696); Disseminated Intravascular Coagulation (DIC) (1813); Sepsis (2067); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study the at of the patient¿s shed blood collected through chest tubes for hemothorax was found to be safe without complications in this study.

Event Description

Received an article titled "early autologous fresh whole blood transfusion leads to less allogeneic transfusions and is safe".The purpose of the article was to assess outcomes in trauma patients receiving whole blood autotransfusion (at) from hemothorax.Per the article adverse events included adult respiratory distress syndrome, disseminated interstitial coagulation, sepsis, renal insufficiency and transfusion related acute lung injury.

• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7535864
• MDR Text Key: 108976662
• Report Number: 3011175548-2018-00501
• 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: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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): Required Intervention