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

Model Number 3600-100

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The dye ball that is in the water seal chamber was stuck pretty high up and would not come down with both drainage systems.

Event Description

N/a.

Manufacturer Narrative

Analysis: the oasis chest drain was not returned.No product number or lot number was provided.Multiple attempts to obtain more detailed information from the physician were requested.No responses from the physician were received.As stated in the instruction for use (ifu): ¿manual high negativity vent: to lower the height of the water seal column and to lower chest drain vacuum pressure when connected to suction, depress the high negativity vent located on top of the drain until the water seal column lowers to the desired level.¿ conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the oasis chest drain was faulty.

• 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: 8451401
• MDR Text Key: 139967349
• Report Number: 3011175548-2019-00310
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention