Administration of blood products through the Alaris ... - CareFusion

Administration of blood products
through the Alaris ®
SE pump
(Models 7100 and 7200)
Rodney A. Hasler, ME
Sr. Clinical Study Specialist
Note: This white paper was published prior to the release of models 7130 and 7230. However, this white paper also
applies to these models as the mechanisms are identical.
Summary
Studies have been performed by an independent
laboratory to screen for potential pump-induced
hemolysis with the Alaris SE pump. These studies
indicate no clinically significant hemolysis is induced by
delivering blood products with an Alaris SE pump and
model 72980 blood administration set or model 72023
administration set. Additionally, there did not appear to
be any substantial adherence of platelets to the infusion
set, nor was there significant release of cytosolic LDH due
to membrane damage.
Pump assisted transfusion has become common practice.
The convenience, improvement in flow rate control and
volume control afforded by infusion pumps make them
an attractive alternative to pressure sleeve or gravity
infusion of blood products.
When IV infusion pumps are used to infuse blood
products, the concern most often expressed is whether
passage through the pump mechanism contributes
significantly to hemolysis of red blood cells. Many factors
may affect hemolysis during transfusion (see Table 1).
Because the influence of any combination of these
factors may converge on a given transfusion event, it
has been difficult for clinicians to establish guidelines
that define acceptable cell damage. For example, FDA
guidelines for the evaluation of shelf life require post-
transfusion survival of red cells to be only 75% of the
cells initially present when the unit was drawn. 1 In many
instances the relationship between the amount of blood
product infused and the resulting clinical response is not
known. Of course the clinical condition of the patient
will determine individual tolerance to infusion of red cell
breakdown products.
There is a great deal of variation in transfusion practices
among institutions. Infusion pumps do not completely
automate transfusion, and are not intended to replace the
nurse or other professionals in monitoring the process. For
example, red cells tend to clump and settle in the blood bag
prior to entering the tubing. The bag still must be mixed
occasionally to resuspend the cells, as is common transfusion
practice with or without pump-assisted administration.
Table 1: Factors affecting hemolysis during blood
product transfusions
Type of blood component
Age of the blood product
Viscosity
Storage conditions (temperature, preservatives,
container material)
Handling (agitation, kneading to re-suspend
settled cells)
External pressure applied to the blood bag
In-line blood filters (pore size, filter material, degree
to which clots occlude surface area)
Interaction between blood components and fluid path
surfaces or materials
Type of mechanical infusion device, if any
Infusion rate
Needle or catheter gauge

Methods
P.D. Mintz, MD, Associate Professor of Pathology and
Internal Medicine, and G. Anderson, SBB (ASCP),
University of Virginia Health Sciences Center, performed
studies in 1994 on the Alaris SE pump model 7100 with
model 72980 blood administration set and model 72023
administration set. 2
Four units of red blood cells (adenine-saline added, AS1)
and four pools of platelets per set were pumped in a
laboratory setting. Testing was performed at or near the
blood products’ outdate. To detect any red cell damage,
mean corpuscular volume (MCV) was measured on
each sample and RBC histograms were printed. Cell-free
supernatants were prepared by double centrifugation and
were measured for free hemoglobin, lactose dehydrogenase
(LDH) and potassium (K+). The hematocrit of each sample
was determined in order to have some measure of the
viscosity of the blood being pumped. Samples for each test
run was collected under the five conditions in Table 2.
Pooled platelets were also tested by sampling at the five
conditions listed in Table 2. Platelet concentration, mean
platelet volume (MPV) and percent LDH release were used
as markers for platelet loss and membrane disruption.
Table 2: Sampling conditions red blood cells and
pooled platelets 2
1. Directly from unit
2. After passage through the filter and administration
set by gravity alone (no pre-priming)
3. After 20 mL of blood/platelets had been pumped
at 999 mL/hr without a needle attached
4. After 100 mL of blood (or 50 mL of platelets)
had been pumped at 999 mL/hr with a 19g
needle attached
5. With needle attached as unit finished
Results
None of the assays for red cell damage displayed clinically
significant differences over their appropriate control. For
the MCV, LDH, K+ and free hemoglobin, there were no
significant differences by examination among sample means.
There was one instance in which the LDH rose by 1,000 U/L
and the K+ rose 12 mmol/L from the unit control to the test
conditions. Since both of these parameters were measured on
the same instrument and the corresponding free hemoglobin
did not increase, this isolated event is most likely a technical
error in the testing (such as a dilution error). The platelet
concentration, MPV and LDH release reflect no significant
differences between the sample means by observation.
Conclusion
The Alaris SE pump with Guardrails ®
software has the same
pumping mechanism, and therefore the same effect on blood
and blood hemolysis. Dr. Mintz and Mr. Anderson concluded
that the Alaris SE pump, when used with model 72980 blood
administration set or model 72023 administration set, did not
induce any clinically significant hemolysis. Additionally, there
did not appear to be any substantial adherence of platelets to
the infusion set, nor was there significant release of cytosolic
LDH due to membrane damage. 2
Discussion
If, upon review of the study methods presented, a hospital
considers its practice to be significantly different, it is
recommended that the institution consider performing tests
for hemolysis on a small series of outdated (worst case) blood
components with the complete setup and under conditions
of flow rate, etc., anticipated in clinical use in the facility. The
term “blood products” is not intended to be all inclusive.
Special applications, such as the delivery of T-cells with the
Alaris SE pump, are considered unique and have not presently
been studied.

References
1 Walker LH. Technical manual 11th Edition. Arlington, VA: American Association of
Blood Banks, 1993.
2 Anderson GT. Evaluation of the IVAC Signature Edition Infusion Pump to Deliver Red
Blood Cells and Platelets. Transfusion, 1994, 34: 664.
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