Report received stated a patient who had a pneumothorax, had a chest tube attached to an oasis chest drain and his condition deteriorated significantly, his condition worsened on chest x-ray (cxr).The drain was changed to another oasis drain and no improvement.The drain was then changed to a thoraseal drain and following a repeat cxr the patient¿s condition had improved.
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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 in good condition and showed signs of blue die indicating that the drain had been filled to the fill line during use.The patient line had been cut on the distal end of the tube.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 drain regulator was still in the pre-set setting of -20ch2o.The vacuum realized at the end of the patient tube was -20cmh2o.The patient line vacuum pressure is accurate to the regulator setting.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 the actual vacuum realized when measured was -39.9cmh2o.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 began to fill using only gravity.Again the drain was operating properly.It is unknown why the drain did not function based on the complaint details however the drain when tested performed properly.Based on the passing results of the device history records as well as the performance of the drain the root cause of the complaint cannot be determined.Clinical evaluation: 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.
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