Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
The purpose of this study is to validate that single units of RBCs collected by the
 Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red
 cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood
 cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using
 LN832 disposable sets for this intended use.
This study will take place at two sites (Blood Center of Wisconsin (BCW) Milwaukee, WI and
 American Red Cross-Norfolk, VA).

 -  A standard double red cell collection protocol will be initiated using the Haemonetics
 MCS®+ 8150 system using LN832 disposable sets. The collection procedure will be
 terminated after collection of one RBC unit. The maximum target red cell volume will be
 selected based on the donor predonation weight as specified in the nomogram included in
 the MCS®+ 8150 operation manual.

 -  The RBC units will be stored for 42 days at 1° to 6°C.

 -  Upon collection and at 42 days after collection, the RBC units will be weighed and
 tested for hematology parameters (white blood cell count, red blood cell count, residual
 white blood cell count, hemoglobin, hematocrit, platelet count, mean corpuscular volume,
 mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cell
 distribution width, and supernatant hemoglobin) and chemistry parameters (pH, potassium,
 glucose, lactate, and ATP).

 -  Acceptance criteria for this study are as follows:

 1. Hemolysis of less than or equal to 1% at 42 days of storage

 2. Maximum absolute red cell volume is less than or equal to the programmed absolute
 RBC target volume + 15%

 3. Minimum absolute red cell volume is greater than or equal to the programmed
 absolute RBC target volume - 15%

 -  After collection of sixty (60) evaluable RBC units, the study will be considered
 supportive of the intended use noted above if zero (0) units fail the acceptance
 criteria.

 -  If one (1) unit fails acceptance criteria after collection of sixty (60) evaluable RBC
 units, an additional seventy one (71) units will be collected.

 -  The study will be considered supportive of the intended use noted above if not more than
 one (1) total unit out of 131 evaluable units fails the acceptance criteria.

 -  If a total of two (2) units fail acceptance criteria, the study will not be considered
 supportive of the intended use noted above.
Inclusion Criteria:

 -  Males and Females ≥ 18 years of age

 -  Males ≥ 130 pounds, Females ≥ 150 pounds

 -  Males ≥ 5 feet, 1 inch, Females ≥ 5 feet, 3 inches

 -  Hemoglobin ≥ 13.3 g/dL

 -  Hematocrit ≥ 40%

 -  Donor Eligibility: Meets all criteria as per sites' Research Blood Donation Record,
 Prior donation date (i.e. not less than 112 days for most recent double RBC unit
 donation, 56 days for most recent single RBC unit donation)

 -  Subject must provide informed consent using an IRB informed consent form prior to
 undergoing any study related procedures.

 Exclusion Criteria:

 -  will be not fulfilling any of the inclusion criteria.