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

Model Number 3600-100

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/29/2017

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.Related mdr: 3011175548-2017-00138.

Event Description

Report received stated that there was a problem with an oasis drain.The nurse reported that they hooked up the drain and the next day the water seal was empty.

Manufacturer Narrative

Additional information received stated that the drains water seal was not filled with water.The instructions for use (ifu) clearly state 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.Based on the complaint details it appears that the complaint was related to operator error.Without the actual drain the complaint cannot be confirmed.Atrium medical does 100% pressure test every chest drain to ensure it is not leaking prior to packaging.A thorough review of the device history records indicated that this lot of drains met all quality inspections and performance criteria.Clinical evaluation: the ifu states water seal and suction control chambers must be filled to prescribed levels prior to use and should be checked regularly to confirm proper operation.Replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.The ifu also states that patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.Chest tubes are inserted for patients with chest wall injuries, punctured lung tissue, and those requiring thoracotomy.Care of the patient with chest tubes includes observing for drainage characteristics, signs of a resolving air leak and prevention of infection.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.

• 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: 6885269
• MDR Text Key: 89375204
• Report Number: 3011175548-2017-00137
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2018
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 242328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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