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

Model Number 3620-100

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 05/21/2018

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 blood was noticed in the waterseal chamber.

Manufacturer Narrative

The drain was received and inspected.The drain was found to have a large amount of bodily fluid still within the drain including in the waterseal portion of the drain.The drain was cleaned and disinfected.A mixture of water and blue die was placed in the drain filling all of the chambers.The result was that no die was leaking into the water seal portion of the drain.The drain was then placed under vacuum to simulate normal use conditions.During the test none of the blue water transferred into the waterseal portion of the drain.All drains are 100% leak tested during the manufacturing process and this lot of drains was found to have met all specifications.Based on the complaint investigation results, the drain is functioning properly and there are no leaks or cracks within the drain.It is not known how bodily fluid collected in the waterseal portion of the drain; however, if a drain is knocked over or allowed to overflow fluid could get into the waterseal portion of the drain.Clinical evaluation: the oasis chest drainage system is indications 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 post-operative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use (ifu) advise to always place chest drain below the patient¿s chest in an upright position.To avoid accidental knock over, open the floor stand for secure placement on the floor or hang the system bedside with the hangers provided.The ifu also states to replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.Related mdr 3011175548-2018-00557.

Event Description

Not applicable.

• Brand Name: OASIS DUAL DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7564226
• MDR Text Key: 110465078
• Report Number: 3011175548-2018-00558
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 426327
• Other Device ID Number: 00650862112016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1