MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN; DRAIN, SINGLE W/AC, S

Model Number 2002-000

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr files: 3011175548-2017-00186, 3011175548-2017-00189, 3011175548-2017-00190, 3011175548-2017-00191, 3011175548-2017-00192, 3011175548-2017-00193, 3011175548-2017-00194, 3011175548-2017-00195, 3011175548-2017-00196, 3011175548-2017-00198, 3011175548-2017-00199.

Event Description

Report received stated that the ocean drain was unable to produce suction.No further information has been provided.

Manufacturer Narrative

Clarification: upon receipt it was noticed that the complaint sample was received unopened and unused.There is no product failure.

Manufacturer Narrative

The drain in question was not returned for an evaluation, therefore the functionality of the drain could not be performed.A review of the device history records indicates that this lot of chest drains passed all quality inspection requirements and no non-conformance reports were generated during the manufacture of the product.Several attempts were made to obtain additional information regarding the event without any success.It is a possibility that the facilities vacuum source was not functioning properly or was not producing the correct amount of suction.Without having the returned unit in question it is impossible to evaluate the functionality of the drain and to determine root cause.Clinical evaluation: the ocean water seal chest drain is indicated for evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.The instructions for use (ifu) states in precautions that patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.The ifu instructs in step 4.Connect suction to chest drain - attach suction line to suction port on top of chest drain.Turn suction source on until constant, gentle bubbling occurs in chamber a.

• Brand Name: OCEAN
• Type of Device: DRAIN, SINGLE W/AC, S
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6963895
• MDR Text Key: 90694985
• Report Number: 3011175548-2017-00197
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/02/2019
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Device Lot Number: 245600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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