MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN DRAIN, TOTAL RECOVERY W/S

Model Number	2050-300
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/15/2016
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.
Event or Problem Description
Report received stated the patient had a recurrent pneumothorax when the drain was removed from the wall suction.
Additional Manufacturer Narrative
Trauma patient presented a hemopneumothorax on the left side.Pneumothorax was apical.Single catheter was placed to remove both air (superior; top of pleural space) and blood (inferior; bottom of pleural space).While on suction the patient was able to drain air and blood without incident.The ocean chest drain had a filled, functioning water seal and was applying the desired suction level thus the device was functioning properly.When the hemothorax stopped the decision was made to discontinue negative pressure therapy and place the patient on gravity drainage.At this time the clinicians did not assess whether patient would tolerate gravity drainage prior to discontinuing suction.An x-ray was taken prior to turning off suction (going to water seal) to confirm the hemothorax resolution.It is unknown if resolution of the pneumothorax was confirmed via x-ray (no space seen at the top of the lung) or via water seal monitoring (cessation of bubbling).While the hemothorax fluid rate had dropped/stopped, the pneumothorax was most likely still present, thus not a 'recurrence'.From the information provided it can be concluded that ocean chest drain functioned properly during set up and during use.The inability of the patient to withstand gravity drainage was not chest drain related but as a result of the discontinuation of suction prematurely.

• Brand Name: OCEAN DRAIN, TOTAL RECOVERY W/S
• Common Device Name: OCEAN DRAIN, TOTAL RECOVERY W/S
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 5948242
• Report Number: 1219977-2016-00200
• Device Sequence Number: 1227239
• Product Code: KDQ
• UDI-Device Identifier: 00650862103069
• UDI-Public: 00650862103069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2016

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: 2050-300
• Device Catalogue Number: 2050-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 09/26/2016
• 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
• Patient Age: 48 YR