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

Model Number 3600-100

Device Problem Suction Problem (2170)

Patient Problem Pleural Effusion (2010)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that the suction part of the chest drain kit was not working properly, not suctioning.When the patient went to radiology for computerized tomography scan, the patient still had 2l of drainage in the pleural cavity.

Manufacturer Narrative

Analysis: as the device in question was not returned a thorough investigation of the physical product could not be conducted.The product lot number was also not provided; as such a review of the device history records could not be conducted.During the manufacture of the oasis chest drains every drain is 100% inspected to ensure there are no leaks in the drain.The details provided indicate that the nurses confirmed that the drain was not suctioning even though the suction at the wall was working properly.Based on the details it appears as if the catheters used in the case may not have been placed properly in the patient¿s chest wall cavity as even if the chest drain was not under vacuum the fluid would drain by gravity if placed on the floor or bed rail as specified in the instructions for use.This cannot be confirmed however as the institution has not responded to any of the questions asked of them after three good faith efforts.Conclusion: based on the details of the complaint atrium medical corporation cannot conclude the oasis chest drain was faulty.It is possible that the catheters were not placed properly in the chest cavity during the procedure.If this was the case it would explain why there was 2 liters of drainage still in the pleural cavity.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.It also facilitates postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.If a chest tube is not draining as expected, it may be the result of obstruction of the tube, disconnection, inadequate suction or displacement of the tube within fluid compartment.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 SINGLE CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• MDR Report Key: 10041062
• MDR Text Key: 190676496
• Report Number: 3011175548-2020-00652
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1