Clinical Evaluation of the OrthoPAT Advance System

Inclusion Criteria

• Male or female over the age of 18 years
• Subject is scheduled for a total knee/hip replacement/ revision or a hysterectomy.
• Subjects determined eligible per site standard of care for use of intra- and post-operative use of cell salvage device

Exclusion Criteria

For subjects where product is transfused

• Subject is undergoing a trauma procedure where there is a possibility of contamination from an open wound.
• Patient is diagnosed with sepsis.
• Patient is diagnosed with sickle-cell anemia.
• Malignant cells may be mixed with blood salvaged from the surgical field.
• Prostatic or amniotic fluid is mixed with blood salvaged from the surgical field.
• Blood salvaged from the surgical field may be contaminated from an active infection at wound/drain site.
• Blood salvaged from the surgical field contains topical hemostatic agents, anti-bacterial agents, or wound irrigants not intended for parenteral use.

For all subjects:

• Subject is undergoing a procedure which involves high, rapid blood loss such as liver transplants, certain cardiovascular procedures, and trauma procedures where blood loss is high (per Investigators judgment).
• Any procedure terminated prior to completion by subject request, operator decision or error, or device error.
• Any subject with which at least 200mL of filtered blood or 1 full disc is not available for processing and data collection within the study.