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

Model Number 3600-100

Device Problems Air Leak (1008); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

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.

Event Description

Report received stated that an oasis drain had an air leak that could not be resolved.The release on the back of the drain was pressed and it did not work.The drain was replaced with a new drain without any issues or patient harm.

Manufacturer Narrative

The drain was not returned so an evaluation of the actual unit could not be performed.There is no way to determine if the oasis chest drain was actually performing improperly.All chest drains are 100% vacuum pressure leak tested to ensure the integrity of the chest drain in process prior to packaging.The product lot number was not provided, therefore a device history record review was unable to be performed.Because the oasis chest drain was not returned there is no way to determine the cause of the complaint.Functional testing of the drain would have been performed if the drain was returned to determine the cause of the complaint.Based on the details of the complaint atrium can find no fault with the product.The oasis thoracic drainage system is intended to re-establish lung expansion and restore effective breathing dynamics.It will evacuate air and/or fluid from the chest cavity or mediastinum.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there was a loose connection between the patient and the drain.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.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.

• Brand Name: OASIS DRAIN
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6593119
• MDR Text Key: 76146971
• Report Number: 1219977-2017-00077
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 72 YR
• Patient Weight: 105