MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problems Excess Flow or Over-Infusion (1311); Suction Problem (2170)

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

Event Date 07/17/2017

Event Type  Injury  

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 a trauma patient's drainage overflowed the chest drainage unit while on suction and the drainage was sucked into the wall by wall suction.

Manufacturer Narrative

Based on the details provided, it is not possible to determine if the chest drain was faulty.The lot number of the chest drain was not provided.If it had been provided a full review of the device history records would have been conducted to ensure there were no manufacturing issues related to the complaint during the production build.The investigation could not confirm the complaint as the chest drain was not returned and the lot number was not provided.Based on the details it appears that the drain was filling faster than the observation rate of every 3 to 4 hours causing the drainage to back up into the wall.Clinical evaluation: the oasis bru drain is indicated for evacuation of air and/or fluid from the chest cavity or mediastinum, to help re-establish lung expansion, to restore breathing dynamics and to facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.Chest tubes are inserted for patients with chest wall injuries, punctured lung tissue, and those requiring thoracotomy.Care of the patient with chest tubes includes observing for drainage characteristics, signs of a resolving air leak and prevention of infection.Meticulous sterile technique, insertion site care and drainage system setup are key components of chest tube management.The instructions for use (ifu) precaution that the chest drain needs to be replaced when collection volume meets or exceeds maximum capacity.It also states that patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6731722
• MDR Text Key: 80663895
• Report Number: 3011175548-2017-00045
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention