The brat 2 autologous blood salvage system.
The medwatch report indicated that the blood processed from the cell saver started to separate in the iv blood pump.
Transfusion was discontinued before reaching the pt.
The risk mgmt mgr was contacted and indicated that the processed blood appeared to be fine until it was pumped through the iv blood pump.
At that point, the blood appeared to be hemolyzed with clumps.
The risk management mgr stated that there was no pt involvement.
The blood was not transfused to the pt.
Sorin group usa requested to have the brat disposables returned for eval.
The risk management mgr did not know if the disposable had been discarded.
To date, the mgr has not responded regarding the disposition of the disposables.
If the product is returned for eval, a follow-up report will be filed.