(b)(6) patient developed pump thrombus, leading to death.Detail of note: pump analysis says 'external factors' deformed the pump, causing the impeller to make contact with rear housing.Treatment summary: the patient was admitted for ventricular assist device (vad) high power and suspected thrombus.In addition, the patient was showing signs and symptoms of heart failure and their international normalized ratio (inr) was 2.6.The patient was given 2 doses of tissue plasminogen activator (tpa) to treat the thrombus.After the tpa treatment, the patient experienced changes in mental status and a hemorrhagic stroke.The patient continued to decline neurologically, and an electroencephalogram (eeg) showed continuous seizing.The decision was made to withdraw care and the patient subsequently passed away.Device analysis: analysis of the pump revealed the device did not pass visual inspection or dimensional verification.Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller.These mechanical abrasions of the lower housing ceramic surface and matching surface of the impeller are indicative that an external factor may have forced the impeller against the rear housing which led to scoring marks observed during visual inspection.Dimensional verification revealed the front and rear housing disc curvatures were found to be deviating from specifications.
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