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

Model Number 3600-100

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 the drain exhibited constant bubbling in water seal.

Manufacturer Narrative

The drain was received and inspected.The drain was clean and contained no bodily fluids.The water seal contained sterile fluid that had been added to the required fill line.The drain was set-up and tested per the instructions for use (ifu).To ensure the chest drain was not leaking, a vacuum of -109mmhg was applied.The patient side tube was clamped off and no bubbling was detected with the regulator set at -10cmh2o.The regulator was then cycled up to -40cmh20 with no bubbling seen.The clamp pressure was released and rapid bubbling occurred as expected.The end result is a fully functional chest drain with no leaks.A review of the device history records found that the product met all specifications.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 drain is intended to evacuate air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics as well as to facilitate collection of autologous blood for reinfusion.The instructions for use (ifu) state patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation and that the suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2o or greater.The water seal is a feature on the drain that provides a visual cue that there is an air leak.Gentle continuous bubbling indicates suction is operative.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY SINGLE 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: 6860689
• MDR Text Key: 86111852
• Report Number: 3011175548-2017-00123
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 236096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• 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