During initial visual examination of the returned products a defect at end of the inflow cannula transverse to the flow direction was detected.The breach was located below the edge of the connector, in the section between connector and outer velour of the cannula.Ct-scan was done for both cannula ends (inflow & outflow).The results of the ct-scan confirmed the defect at the end of the inflow cannula.The geometry and the structure of the breach in the cannula wall of the inflow cannula leads to the assumption that a high external force on the cannula occurred.Further detailed investigation showed multiple traces on the inner surface of both cannulas due to strong overload in the section between connector and outer velour of the cannulas.Additionally, it can be noted, the cannulas, especially the inflow cannula, might have been stretched and kinked several times in the same direction caused by moving the pump upright from the patient's body during excessive movement from the patient.Due to the remaining length of the distal end of the cannula without polyester velour covering was very small, the flexibility of the cannula wall was severely restricted.This could have led to increased internal material stresses in the silicone of the cannula wall and may have contributed to the fracture of the cannula wall due to external kinking and/or tensile stress.The combination of the occurrence of high external forces on the cannula over multiple times and the limited distance between connector and velour, can be assumed as cause for the breach in the cannula wall.
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