The drain was not returned so an evaluation of the actual unit could not be performed.There is no way to determine if the oasis chest drain was actually performing improperly.All chest drains are 100% vacuum pressure leak tested to ensure the integrity of the chest drain in process prior to packaging.The product lot number was not provided, therefore a device history record review was unable to be performed.Because the oasis chest drain was not returned there is no way to determine the cause of the complaint.Functional testing of the drain would have been performed if the drain was returned to determine the cause of the complaint.Based on the details of the complaint atrium can find no fault with the product.The oasis thoracic drainage system is intended to re-establish lung expansion and restore effective breathing dynamics.It will evacuate air and/or fluid from the chest cavity or mediastinum.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there was a loose connection between the patient and the drain.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.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.The instructions for use provide a thorough written and visual instruction for the clinician.Even with provided instructions for use it is essential for proper education and periodic review with all staff involved in the set up and use of a product helps to ensure confidence.
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