MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN SINGLE DRAIN

Model Number	2002-400
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional 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's: 1219977-2017-00096, 1219977-2017-00098, 1219977-2017-00099, 1219977-2017-00100.
Event or Problem Description
Report received stated a doctor was having an issue with a patient regarding a collapsed lung when using an ocean drain.
Additional Manufacturer Narrative
The drain was not returned for evaluation therefore there is no way to determine if the chest drains was performing improperly.The details provided stated the drain was held at -70mmhg for 3 days.This caused chamber "a" of the drain to run dry.The drain needs to be checked periodically to ensure it is running properly.When chamber "a" is allowed to run dry the suction created in the drainage system returns to atmospheric pressure, causing no suction.A review of the device history records was performed and the drain lot was found to have met all specifications.The ifu states the following: "water seal and suction control chambers must be filled to prescribed levels prior to use and should be checked regularly to confirm proper operation".Based on the details provided with the complaint the most plausible explanation is that the vacuum applied to the chest drain (-70mmhg) was much higher than the normal amount creating rapid bubbling of the fluid in chamber "a" causing the water in this chamber to evaporate.This created a condition where no suction was being applied.Based on the details of the complaint atrium can find no fault with the chest drain.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 is also used to facilitate post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.Clinical practice guidelines advise to check and recheck all equipment and connections.The instructions for use provide a thorough written and visual instruction for the clinician.Even with provided instructions for use it is essential for proper education and periodic review with all staff involved in the set up and use of a product helps to ensure confidence.The instructions for use (ifu) states that the water seal and suction control chambers must be filled to prescribed levels prior to use and should be checked regularly to confirm proper operation.Patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OCEAN SINGLE DRAIN
• Common Device Name: OCEAN SINGLE DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6660040
• Report Number: 1219977-2017-00097
• Device Sequence Number: 210493
• Product Code: KDQ
• UDI-Device Identifier: 00650862100211
• UDI-Public: 00650862100211
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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
• Operator of Device: Physician
• Device Model Number: 2002-400
• Device Catalogue Number: 2002-400
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention