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

Model Number 3600-100

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

Patient Problem No Code Available (3191)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated the color of the fluid in the chest drains water seal chamber was found to be incorrect.

Manufacturer Narrative

The unit was not returned for evaluation.The ocean chest drain as provided has a blue dye ball in the water seal chamber of the drain.This ball upon contact with the sterile water turns the water a blue color.The image provided indicates that the color of the water was a pale greenish and not blue as expected.Based on the image it is most likely that the drain was knocked over during using causing bodily fluids to run into the water seal side of the drain.This would explain the difference in color and the partial amount of fluid in each of the three collection columns.The lot number of the drain was not provided therefore a device history record review could not be performed.The ocean chest drainage system is indicated for use in the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.When a chest drainage collection canister tips over so that fluid leaks from one chamber to the next it could possibly cause an interruption in therapy to the patient resulting in a longer recovery period.The instructions for use (ifu) advise to always place the chest drain below the patient¿s chest in an upright position.To avoid accidental knock over, open the floor stand for secure placement on the floor or hang the system bedside with the hangers provided.

• Brand Name: OCEAN 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: 7248268
• MDR Text Key: 99236300
• Report Number: 3011175548-2018-00127
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K831931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

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: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Other Device ID Number: 00650862100013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/26/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 83