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

Model Number 3600-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012)

Event Date 12/16/2017

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 patient on a thora-seal chest drain was switched to a heimlich valve for computed tomography (ct) purposes.On preparation for transfer to intensive care unit (icu), they attached oasis chest drain on gravity drainage with a 24fr catheter, within minutes the patient developed a tension pneumothorax, cardiac arrest and they had to remove the air by syringe to decompress the tension.

Manufacturer Narrative

The unit was received and inspected.Upon initial inspection of the chest drain, the original packaging materials that protect the drain were not provided.The drain was not cleaned prior to shipment, therefore the drain had to be disinfected prior to testing.To determine if the returned drain was operating properly the drain was prepped per the instruction for use and a vacuum of 109cmh2o was applied to the suction nozzle.The vacuum realized at the end of the patient tube was -20cmh2o but was fluctuating as there was rapid bubbling in the water seal.This indicates that there is an air leak in the system.When the vacuum was applied the fluid in the test beaker was easily transferred into the drain.This was then repeated with the drain regulator set to -40cmh2o.Again the output was measured and was also accurate to the regulator setting but still indicating that there was an air leak.The drain was then tested to ensure it would work properly when set up using only gravity.The chest drain was placed on the floor below the test bench.The test bench is 34in above the drain.The drain patient line tubing was placed in a 10,000ml glass beaker filled with water and blue dye so as the evacuation is easily seen.Upon placing the drain line tube into the glass beaker the drain would not function under gravity as an air leak was present at the connection of the catheter and the drain line.This was evident as rapid bubbling of the water seal was noticed.The leak was small enough that the wall suction was able to overcome the leak but large enough to prohibit the functionality under gravity.The drain line was cut just prior to the drain line catheter connection ultimately removing the air leak and the gravity test was re-started.The drain was filling properly after removal of the bad connection to the catheter.The catheter attached to the drain line was not a product manufactured by atrium medical.Based on the test results the connection of the catheter to the patient line had an air leak prohibiting the chest drain from functioning properly under gravity.Once the leak was removed the drain operated properly under gravity.The oasis chest drain is indicated for use in evacuating air and/or fluid from the chest cavity or mediastinum, 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.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.

• Brand Name: OASIS SINGLE 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: 7154334
• MDR Text Key: 96045672
• Report Number: 3011175548-2017-00422
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: P17215
• Other Device ID Number: 00650862110012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• 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