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

Model Number 3600-100

Device Problems Suction Problem (2170); Noise, Audible (3273)

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

Event Date 11/02/2018

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 that a chest drain was connected to the chest tube and the drain was making a humming sound and did not appear to have proper suction.All of the connections were checked to see if there was a leak and none were found.A new chest drain was opened and attached and the issue was resolved.

Event Description

N/a.

Manufacturer Narrative

The drain was received and inspected.There was a small amount of dried blood in the first collection chamber.The drain was set up per the instructions for use (ifu).The water seal chamber was still filled to the proper 2cm fill line per the instructions for use.The drain was then placed under vacuum.The vacuum setting of the drain regulator was not moved and was at the shipped setting of -20 cmh2o.The wall vacuum pressure was set to -109mmhg and the suction tube was placed on the suction port of the drain.No unusual noises were noticed.The regulator of the drain was cycled down to -10cmh2o and all the way to the maximum setting of -40cmh2o.Still no humming sound was heard.The vacuum pressure was then increased to -140mmhg.When this high negative pressure was applied there was still no humming noise coming from the chest drain.The chest drain in all instances was functioning properly.The device history records associated with this lot of drains were reviewed and found to be complete and have met all the finished good specifications.Clinical evaluation: the oasis single 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.The instructions for use (ifu) states the suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2) or greater.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8124922
• MDR Text Key: 129301555
• Report Number: 3011175548-2018-01429
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 426318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Device Age: YR
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR