[113638828]
Massive hemolysis, no right heart support despite flor readings of 3 liters per minute - worsening shock. Pt was receiving from complex aortic root surgery and was on partial right heart support with ecmo (extra corporeal membrane oxygenation), for 18 hrs and slowly improving. Impella rp inserted in the cath lab while ecmo was wearing. Impella rp read flows of 2. 8 to 3. 1 liters per minute. However despite good lv function. The left ventricle was not filling (suggesting that impella rp was not working). Lactate kept going up. Blood showed hemolysis. Ldh kept going up. Urine turned black and stopped. As an emergency, the impella rp was taken out and ecmo re-instituted. When the impella rp device was shut off, and cut, there was no change to hemodynamics. Everything got better with ecmo. However, 8 hours of profound hemolysis and negative effects on the right heart caused kidney, liver and multi - organ failure and death. Complex aortic root reconstruction 2 days before impella rp came out, performed for a very heavily calcified bicuspid aortic valve with severe stenosis and a narrow aortic root. S/p aortic valve replacement and aortic root reconstruction. Dates of use: 15. 30 hrs, (b)(6) 2018; 0230 hrs, (b)(6) 2018. Diagnosis or reason for use: right heart failure. "is the product compounded: no; is the product over-the-counter: no. " event abated after use stopped or dose reduced: yes. Abiomed, inc.
Patient Sequence No: 1, Text Type: D, B5