4-4
Ensuring Safety and Quality for a PCS2 Procedure
P/N 85266-30, Manual revision: A
Avoiding bowl
misalignment
An improperly installed disposable bowl can become misaligned as it spins. This
can create excessive friction, and consequently overheat the bowl contents. The
operator should verify the alignment of the bowl at the time of installation.
Warning: The operator must not use any bowl which cannot be properly seated
in the centrifuge chuck. Overheating can occur, subsequently lead to hemolysis
and make any blood being processed unsafe for reinfusion. During operation
the operator should interrupt the PCS2 procedure if an abnormality or noise ap-
pears, related to the spinning bowl.
Avoiding
overheating due
to mechanical
situations
Overheating could also result from a mechanical or maintenance-related
problem, such as a defective bearing or seal within the centrifuge well. In this
case, the operator should contact the local Haemonetics representative and
discontinue use of the PCS2 device until it is serviced.
Warning: If any component of the PCS2 device has become overheated during
a procedure, and thus overheats the blood being processed, the blood compo-
nents cannot be considered safe for re-infusion.
Controlling for
Red Cell Overrun
Red Cell Overrun is the term used to describe the presence of erythrocytes in the
effluent tubing and/or product collection container during a plasmapheresis
procedure. It is important that the operator observe the appearance of the plasma
as it is collected. A pink or reddish hue could indicate a possible red cell spillage
or a PCS2 malfunction resulting in severe hemolysis. The situation should be
investigated immediately.
If the cause of the reddish hue cannot be determined, the procedure should be
discontinued immediately and the blood components in the bowl must not be
returned to the donor.