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

Model Number 3620-100

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

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 the nurse had difficulty removing the cap from the patient line tubes on the oasis dual drain.

Manufacturer Narrative

The unit was received and inspected.The yellow cap was pulled of the flanged connector without any difficulty.There is moderate resistance by design as the yellow cap could fall off otherwise.A review of the device history records shows that this lot of chest drains met all requirements including the incoming inspection records for the tube sets that contain the yellow caps.Based on the details of the complaint and analysis of the returned product, the connectors were able to be removed without difficulty, therefore atrium could not find any fault with returned unit.Clinical evaluation: the oasis chest drain system is indicated 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 postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.If the clinician has difficulty in the setup of the drain it could potentially represent a delay in treatment for the patient.Clinical education and comprehension is imperative to the success in the setup of a chest drainage system and the delivery of the necessary therapy.The product is labeled so that a practitioner is properly informed of the intended use and indications of the device.

Event Description

N/a.

• 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: 7786353
• MDR Text Key: 117258439
• Report Number: 3011175548-2018-00878
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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