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

Model Number 3600-100

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

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 that the customer noticed a hissing leak/whistle coming from the drain.A new chest drain was opened and attached and the issue was resolved.

Manufacturer Narrative

The oasis dry suction chest drain was returned and evaluated to determine the cause of the complaint.The drain as received had a poorly constructed patient line connection that was filled with plural fluid from the patient.The tube was disconnected as it was badly contaminated.The main drain was disenfected so it could be safly handled.Once disenfected the drain was set up per the instructions for use).The water seal chamber was filled to the proper 2cm fill line per the instructions for use.The drain was filled with water just above the 20ml line as it was with the plural fluid before it was decontaminated.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 above -80 mmhg.Upon applying the vacuum the drain functioned properly without any abnormal sounds.The regulator of the drain was then cycled down to -10 cmh20o and all the way back up to the maximum setting of -40cmh2o.There were no unexpected noises coming from the drain it functioned properly.A full review of the device history records was conducted.The review indicates that this lot of chest drains met all quality and performance criteria.There were no non-conformances related to the complaint.Based on the results of the investigation and the details provided, atrium medical corporation cannot conclude that the device was at fault.All drains are 100% pressure tested to ensure the integrity of the product.The device history records indicate that this lot of oasis dry suction chest drains passed all quality and performance requirements.It is possible the connection of the chest tube to the patient line was making a hissing noise but this could not be confirmed.

Event Description

N/a.

Manufacturer Narrative

Additional information section: d10.

Event Description

N/a.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8681423
• MDR Text Key: 147459349
• Report Number: 3011175548-2019-00640
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 444483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1