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The performance of the Sorin Xtra® Autotransfusion System (ATS) was studied in 62 patients undergoing coronary artery bypass grafting. Blood was collected intraoperatively and washed using three different wash sets in 4 groups. Both collected and washed blood were analysed for hemoglobin levels and hematocrit, concentrations of proteins, albumin, heparin and plasma free hemoglobin (PFH) were determined, erythrocytes, platelets and leukocytes were counted. Hematocrit measurements of the Xtra® were compared with laboratory measurements to study the accuracy of the Xtra® hematocrit sensor. In addition, the red blood cell recovery rate and elimination rates were calculated to evaluate the clinical performance of the Xtra®. The Xtra® ATS produced a volume of concentrated red blood cells with an average hematocrit from 58% to 63%, depending on the size of the bowl and the chosen default program. In all bowl sizes and programs, the Xtra® Hct-out measurement underestimated the CELL-DYN measurement by approximately 15%. The calculated recovery rates for red blood cells (RBC) in the 4 groups ranged from 86.7% to 91.6%. Elimination rates were calculated in each group for proteins (96.8-99.2%), albumin (96.4-98.7%), plasma free hemoglobin (83.6–91.2%), heparin (98.8-99.9%), platelets (82.4-94.3%) and white blood cells (28.6-42.3%). The Xtra® ATS can be appealing for its performance by producing high hematocrit levels in the washed RBC volume, while keeping RBC recovery rate at the same high level (≈ 90%) as in its predecessor, the Electa® Autotransfusion System.

Background: The introduction of new and more advanced technology in healthcare occurs with an increasing speed. Therefore, more attention is needed for safety evaluation of new devices or techniques from an end-user perspective, especially when (inter-) national perfusion safety standards are lacking. A recently increased awareness of the safety risks as a consequence of technical or human error has provoked interest in optimisation of perfusion methodology and devices. To prevent or reduce the severity or likelihood of failures of new technology, ‘failure mode effect analysis’ is a proven proactive technique. When it is used as a qualitative analysis for possible hazards in patient treatment associated with the use of medical devices, it’s called healthcare failure mode effect analysis (hFMEA). Methods: To evaluate the safety of the Extra Corporeal Circulation Optimized (ECCO, Sorin Group, Mirandola, Italy) miniaturized bypass circuit, hFMEA was used. A multi disciplinary team that consisted of two clinical perfusionists, a clinical physicist, a clinical physicist trainee and a technician has performed this analysis. Results: The hFMEA demonstrated that failure of the bubble sensor for the electric remote clamping system on the arterial line (Figure 1), activated by air passing the venous bubble trap, had the highest risk score of all failure modes. This has led to the implementation of an extra low-level sensor in the system to prevent air passing through into the centrifugal pump. The hFMEA has also indicated that extra individual simulation training is needed for handling critical failures during the use of the miniature bypass system. Conclusion: Early identification of possible technology failures in any process or device can avoid adverse patient outcomes. The technique of hFMEA is a valuable tool in evaluating the use of high-risk apparatus, such as an extracorporeal bypass system, in patient treatment in order to increase patient safety.