The syncardia 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.The tah-t remains implanted, therefore it was not returned to syncardia for evaluation.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.A definitive root cause cannot be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).
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The customer, a syncardia certified hospital, reported that the patient had increasing hemolytic markers and was anuric and remained on continuous veno-venous hemodialysis (cvvhd).The customer also reported a week later that the patient's hemolytic markers were on a downward trend and found liver damage as the most likely cause of the hemolysis.The customer also reported an additional week later that the physicians think the patient may have had a thromboembolic event in the liver causing injury resulting in elevated liver enzymes, lactic acid and hemolytic markers.
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