MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DUAL DRAINS; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

At recent in-service, there was discussion regarding the dual drain model concerning tip over (when the device is knocked over, the fluids from either fluid collection compartment can cross over into the other).There were questions regarding how best to observe/record the fluid levels on the collection chamber fronts as the milliliters (ml) values change at various points.There is no patient associated with this report.

Manufacturer Narrative

In regards to the drain being knocked over and the fluid going into the other chambers, the atrium medical corporation drains must be kept in the upright position as specified in the instructions for use.¿placement of unit: always place chest drain below the patient¿s chest in an upright position.To avoid accidental knock-over, place the unit on the floor or hang it bedside with the hangers provided.¿ if a drain is knocked over the fluid will go into the other chambers.In regards to how best to observe/record the fluid levels on the collection chamber fronts as the ml values change at various points.The chest drain front panel has the milliliter graduations that are very clear and legible.It is up to the user to determine how they prefer to view this.Summary - based on the results of the investigation the concerns viewed are covered within the instructions for use and user preference.

• Brand Name: OASIS DUAL DRAINS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8570355
• MDR Text Key: 143737553
• Report Number: 3011175548-2019-00496
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention