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

Model Number 3620-100

Device Problem Occlusion Within Device (1423)

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 unit was not returned therefore the complaint could not be confirmed.As this complaint is associated with another complaint from the same facility in which the device was returned and found to be fully functional and not defective it is reasonable to suggest that this drain was functional as well as it is from the same lot of oasis chest drains.All drains are 100% leak tested during the manufacturing process and this lot of drains was found to have met all specifications.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 3011175548-2018-00558.

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: 7564224
• MDR Text Key: 110122836
• Report Number: 3011175548-2018-00557
• 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

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/29/2018
• 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