MAUDE Adverse Event Report: ATRIUM MEDICAL OASIS SINGLE DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Hospital reported problem during connection of an oasis chest drain to a patient with pneumothorax in which they reported a malfunction of high negative relieve valve.No patient harm resulted due to early identification and replacement with another chest drainage unit.

Event Description

N/a.

Manufacturer Narrative

Investigation: the returned drain was evaluated to determine the cause of the complaint.Upon initial inspection it would appear that the drain was unused as it showed no signs of bodily fluid in any of the tubes or chambers within the drain.The cleanliness of the drain was unexpected as the details provided indicated that there was ¿large chronic pleural fluid accumulation¿.The drain was set up per the instructions for use and the air leak chamber had already been filled to the proper fill line.An external vacuum of -80 mmhg was applied to the suction nozzle.The drain performed properly.Once the suction was removed the float ball then moved to the top, again as expected because the pressure in the drain was not released.Again this is normal function.The pressure release or manual vent tab on the back of the drain was depressed and the pressure within the drain dropped as expected.The ball dropped down to the bottom of the site window.The drain was operating properly.There were no signs indicating that the drain was not performing properly.The suction was then re-applied to the drain and the regulator cycled from -10cmh2o to -40cmh2o and the output pressure verified.The regulator was regulating the vacuum pressure properly.Summary/conclusion - based on the results of the investigation whereas the drain in question performed properly atrium medical corporation cannot conclude that the drain was faulty.A review of the device history records for this production build of drains indicates that this production lot of drains passed all quality and performance requirements.Clinical evaluation: the oasis chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.The system also facilitates postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use (ifu) precaution 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 SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8179222
• MDR Text Key: 131000656
• Report Number: 3011175548-2018-01504
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 427432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1