Cardiotomy Reservoir Testing for
Cardiopulmonary Devices
Cardiotomy reservoirs are critical components in extracorporeal circulation systems, serving as collection chambers for blood suctioned from the surgical field during cardiopulmonary bypass. Their role is essential: ensuring safe blood handling, effective defoaming, and stable flow before reinfusion into the patient. Because they directly impact patient safety and surgical outcomes, cardiotomy reservoirs must undergo rigorous validation to meet international standards.
At our laboratory, we provide comprehensive testing services for cardiotomy reservoirs, helping manufacturers demonstrate performance, safety, and compliance with global regulatory requirements.
- Capacity & Flow Performance:
Verification of reservoir volume, flow stability, and pressure characteristics under simulated clinical conditions. - Defoaming Efficiency:
Assessment of air removal and bubble management to ensure safe reinfusion. - Hemocompatibility:
Assessment of blood-material interactions to minimize hemolysis, platelet activation, and clot formation. - Structural Integrity:
Mechanical testing for durability, leakage resistance, and connector reliability. - Regulatory Documentation:
Comprehensive reporting aligned with ISO and FDA guidance to support CE and global approvals.
- Patient Safety:
Reliable reservoir performance ensures safe blood handling and reduces risks of embolism or blood damage. - Performance Assurance:
Rigorous testing confirms reservoirs meet clinical demands during complex surgical procedures. - Design Optimization:
Data-driven insights guide improvements in reservoir geometry, filter systems, and biomaterials. - Accelerated Market Access:
Compliance-driven testing streamlines regulatory pathways and builds confidence with clinicians and stakeholders.
By combining advanced instrumentation, expert analysis, and strict adherence to international standards, we help manufacturers validate the safety and performance of their cardiotomy reservoirs. Partnering with us means confidence in compliance, innovation, and patient protection.