We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr files: 3011175548-2017-00186, 3011175548-2017-00189, 3011175548-2017-00191, 3011175548-2017-00192, 3011175548-2017-00193, 3011175548-2017-00194, 3011175548-2017-00195, 3011175548-2017-00196, 3011175548-2017-00197, 3011175548-2017-00198, 3011175548-2017-00199.
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The drain in question was not returned for an evaluation, therefore the functionality of the drain could not be performed.A review of the device history records indicates that this lot of chest drains passed all quality inspection requirements and no non-conformance reports were generated during the manufacture of the product.Several attempts were made to obtain additional information regarding the event without any success.It is a possibility that the facilities vacuum source was not functioning properly or was not producing the correct amount of suction.Without having the returned unit in question it is impossible to evaluate the functionality of the drain and to determine root cause.The ocean water seal chest drain is indicated for evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.The instructions for use (ifu) states in precautions that patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.The ifu instructs in step 4.Connect suction to chest drain - attach suction line to suction port on top of chest drain.Turn suction source on until constant, gentle bubbling occurs in chamber a.
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