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

Model Number 3650-100

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

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 bellows on the drain would not expand when on suction.

Manufacturer Narrative

The details provided indicate that the orange bellows did not extend when suction was applied.The returned drain was in good condition and there was a small amount or dried blood within the drain and internal filter.The drain was inspected to determine if there was any damage to the drain.No damage to the drain was noticed.To ensure the chest drain was performing properly and the orange bellows functional, a vacuum of -109mmhg was applied to the suction port of the chest drain.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 in the chamber.The clamp pressure was released and rapid bubbling occurred as expected.The end result is a fully functional chest drain with no leaks and the bellows came out as expected.The bellows of the drain performed properly.Based on the investigation atrium medical corporation cannot conclude that the bellows of the chest drain was non-functional.The bellows performed as expected when the drain was operated.It is possible that the vacuum source at the institution where the drain was used was not functioning properly.The oasis chest drain 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.The instructions for use (ifu) state 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.

• Brand Name: OASIS ATS DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7836922
• MDR Text Key: 119344415
• Report Number: 3011175548-2018-00960
• Device Sequence Number: 1
• Product Code: CAC
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

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 Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1