Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure

Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%

Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.

Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)

Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

Adverse Events

Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.

Time frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.