Health product recall

Ocean Chest Drain

Last updated

Summary

Product
Ocean Chest Drain
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Ocean Chest Drain 443629 2002-400

Issue

This ocean water seal chest drain product code/ref number 2002-400 uses a pre-filled water ampoule for set-up as opposed to a pre-attached funnel for set-up available in all other ocean drain configurations. Visual Iconic set-up instructions were added in the form of an image in 2019 on all ocean drain packaging (on the back of each drain) demonstrating use of a pre-attached funnel, which does not show the user how to fill the ocean water seal chest drain (set-up step) with the use of the supplied water ampoule packaged with the ocean water seal chest drain, product code/ref number 2002-400. However, the instructions for use (ifu) packaged with each case of six (6) ocean water seal chest drains, product code/ref number 2002-400, does include instructions for set up in both drain configurations.
The mismatch between the iconic set-up instructions (funnel technique shown only) and the instructions for use (which contains instructions for both the funnel and ampule technique) created confusion to the user. As a result, the user did not fill the water seal chamber using the sterile water ampoule provided with the drain. With the water seal chamber not having the necessary fluid, the one-way valve to protect the patient was not established and the pleural space was exposed to atmospheric pressure.
The improper set up of the atrium ocean water seal chest drain, product code/ref number 2002-400, could potentially cause delay in treatment or potential harm to the patient. The chest drain attached to the patient for prescribed thoracic drainage therapy must be a 'closed system', thus it requires the establishment of the water seal to protect the patient from atmospheric pressures. Without the necessary closed system, the air within the drain cannot be removed and the risk of a Pneumothorax is established.

 

Recall date: 2021-10-26

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

ATRIUM MEDICAL CORPORATION

40 CONTINENTAL BLVD., MERRIMACK

NEW HAMPSHIRE UNITED STATES

03054

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63554

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