MAUDE Adverse Event Report: ATRIUM MEDICAL OCEAN DRAIN; BOTTLE, COLLECTION, VACUUM

Model Number 2002-400

Device Problem Suction Problem (2170)

Patient Problem No Information (3190)

Event Date 10/30/2018

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 that after wall suction was connected to the drain the fluid from the chamber was drawn into the suction tube.

Manufacturer Narrative

The drain was not returned for evaluation.Several attempts were made regarding the return of the drain without any success.Based on the details of the complaint it would appear that the suction may have been set too high at the source and/or the drain had reached its full capacity and had gone unnoticed.This cannot be confirmed, as no additional details regarding the event have been obtainable.A full review of the device history records was conducted and this lot of chest drains passed all quality and performance requirements.Based on the investigation of the details that were provided, atrium medical corporation cannot conclude that the ocean chest drain malfunctioned in anyway.Clinical evaluation: the ocean chest drainage system is indicated for the evacuation air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.The instructions for use (ifu) state to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and that patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.The ifu also instructs to slowly increase suction to attain gentle bubbling.

Event Description

N/a.

• Brand Name: OCEAN DRAIN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• 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: 8033701
• MDR Text Key: 125974143
• Report Number: 3011175548-2018-01244
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862100211
• UDI-Public: 00650862100211
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 2002-400
• Device Catalogue Number: 2002-400
• Device Lot Number: 425671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2018
• 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