The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (84 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons.The entire membrane consists of an air-side layer, a middle layer and a blood-side layer.In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers.The investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.
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During initial visual examination of the returned blood pump no defect could be detected.For further analysis the pump was disassembled and the membrane layers were individually examined.A leakage was detected in the air-side layer, located at the edge region along the rolling radius of the stabilization ring.Furthermore, graphite agglomerates were found in the membrane interstices.The blood-side layer and the middle layer of the triple layer membrane were found to be intact.The thickness of the defective membrane layer, and the one adjacent was re-measured at fixed points.At the time of investigation, the thickness of the individual layers at all the fixed locations and also at the region of the leakage was found to be within specification.The cause of the failure was most likely the graphite particles that formed due to an abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer of the triple layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion, causing the reduced pump performance (incomplete filling and emptying).Thus, the customer complaint was confirmed.
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