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

Model Number 3620-100

Device Problem Insufficient Information (3190)

Patient Problems Pneumothorax (2012); Complaint, Ill-Defined (2331)

Event Date 07/17/2015

Event Type  Injury  

Event Description

Report stated that physician used a dual chest drain with atmospheric pressure after open heart surgery (coronary artery bypass graft or valve replacement).He connected the tubing to the pericardium and mediastinum.A patient developed peumomediastinum after the surgery.This was found by the chest x-ray on the first day of surgery in the intensive care unit (icu).

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr's: 1219977-2015-00213, 1219977-2015-00214, and 1219977-2015-00215.

Manufacturer Narrative

Engineering analysis: no units were returned for evaluation.Connecting two patient tubes from the same drain to two different sections of the chest cavity (pleural and pericardial spaces) without suction, will result in transfer of air from one space to the other (boyles' law) and would not be effective in removing air from either section.A lack of suction resulted in equilibrium establishing itself between the two spaces and air entering the pericardium.If the unit were used under suction, the air would have been effectively removed from both sections.The instructions for use provide the following in the set-up instructions: "turn suction source on - increase suction source vacuum to -80mmhg or higher.Suction regulator is preset to -20cmh2o.Adjust as required." the complaint ratio for this failure mode is 0.001.Will continue to monitor.Associated mdr: 1219977-2015-00213, 1219977-2015-00214, 1219977-2015-00215.

• Brand Name: OASIS DRY DUAL DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 10 continental blvd.; merrimack, NH 03054-4929 ; 6038645470
• MDR Report Key: 4974913
• MDR Text Key: 6317558
• Report Number: 1219977-2015-00216
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 223979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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