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

Model Number 3620-100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Date 02/01/2017

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

The report received stated that a trauma victim patient required a placement of a single chest tube to drain fluid from the initial trauma.The initial chest drain filled and a new one was needed.The nursing staff switched out the drain and used a oasis dual chamber as a replacement.The chest tube was connected and the second chamber on the device was not needed.However, the tube coming off of the second chamber was not clamped off and was left open.This left the drain system open to outside air and the patient developed a pneumothorax.The pneumothorax was confirmed by a chest x-ray.

Manufacturer Narrative

The unit was not setup properly.The second tube should have been clamped prior to use per the instructions provided.A double collection unit is typically not used when only one chest tube is required.Based on the information provided, the device was not used in accordance with the labeling.Instructions for the proper setup of a double unit are included in the instructions for use (ifu)."dual collection models (2 patient tubes) require both patient tubes to remain connected to the patient.When using dual collection models with only one patient tube connection (1 tube only), the patient tube not in use must remain securely clamped off at all times".

• Brand Name: DRAIN, DRY DUAL W/AC
• Type of Device: OASIS DUAL DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6341911
• MDR Text Key: 67808654
• Report Number: 1219977-2017-00024
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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