MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; DRAIN, DRY DUAL W/AC

Model Number 3620-100

Device Problem Suction Problem (2170)

Patient Problem Pneumothorax (2012)

Event Date 07/26/2017

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 the patient came out of a lung surgery case and started to develop a pneumothorax because the chest drain would not produce suction.

Manufacturer Narrative

The drain upon receipt was contaminated from bodily fluids.Blood was in all chambers and in the water seal chamber.The fluid fill lines that were created by the attending nurse were clearly visible on the front of the drain indicating that the drain was collecting fluid after being connected.Once the oasis chest drain was disinfected the chest drain was set up per the instructions for use to ensure it was functioning properly.The regulator was cycled through the various setting and the results recorded.The drain was cycled from -10cmh2o to -40cmh20.The drain performed properly and no leaks were detected and the proper vacuum was achieved.The drain performed properly when set up following the instructions for use.The lot number was not provided therefore a device history record review could not be performed.The investigation was unable to determine the cause of the complaint based on the details of the event.The chest drains are 100% pressure tested in manufacturing to ensure the integrity of the product prior to shipment.Clinical evaluation: the oasis double 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 may also be used to facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.The instructions for use (ifu) state that the suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2o or greater and that patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.The ifu also states users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY DUAL W/AC
• 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: 6781929
• MDR Text Key: 82398584
• Report Number: 3011175548-2017-00054
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• 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: 08/09/2017

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
• Device Operator: Nurse
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 09/22/2017
• Supplement Dates FDA Received: 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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