The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013.Once the lvad support was initiated and functioning normally, the patient began to have issues with right ventricular function.Right ventricle extracorporeal circulatory support was initiated.As the patient was being transferred from the operating room table to a bed, the outflow cannula for the right ventricle support pump became dislodged from the pulmonary artery resulting in the outflow from the rvad entering the patient¿s mediastinum.The patient¿s chest, which had been packed and covered with an ioban dressing, was quickly accessed and the pulmonary artery cannula was replaced.The extracorporeal circulatory support cannulae had been secured to the skin with multiple sutures and exited out of the superior portion of the sternal incision.During the event, the patient was hypotensive and there was a 15 minute down time.Multiple blood products were administer via rapid infuser.Once the patient was volume resuscitated the rvad and lvad flows stabilized.The patient reportedly recovered enough to be weaned off rvad support after 2 days.However, the patient's neurologic status never improved.Neurology consult found the patient had poor neurologic/brain function and a poor prognosis for recovery.Additionally, the patient developed acute renal failure on top of chronic renal failure, requiring dialysis.The patient was also ventilator dependent due to respiratory failure.The patient continued to experience right ventricular dysfunction requiring further increase in inotropic support.After every attempt was made possible to correct each problem, the patient ultimately succumbed to multisystem organ failure.The patient decided to withdraw care, and several days after the holidays, the family decided to withdraw care.On (b)(6) 2014, all devices were turned off, and the patient quickly expired, with family at the bedside.It was reported that there were no device issues associated with the patient outcome and the devices had operated as expected.
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Describe event or problem: additional information.Correction to brand name, common device name, and model/lot #.Correction to recall: approximate age of device: 6 months correction the device was not returned for evaluation.A correlation between the device and the reported event could not be conclusively determined.The patient and family information for the centrimag ventricular assist system (vas) lists stroke, major bleeding, kidney failure and heart failure as potential adverse events that may be associated with the use of the centrimag system.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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