The excor blood pump,s/n (b)(4) was in use by the patient from (b)(6) 2020 until (b)(6) 2020 (20 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 affected pump has not been returned to the manufacturer.A detailed investigation report will be provided as soon as if it available.
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In the initial visual examination the graphite flakes and dimples the clinic described could not be found.For further analysis, the pump was disassembled and the membrane layers were individually examined.All three layers of the triple layer membrane were intact.Graphite agglomerates were found between the membrane layers.These could be seen as dimples on the membrane surface, confirming this part of the customer complaint.No membrane defect could be detected.The cause of the dimples on the membrane surface is most likely due to graphite particles between the membrane layers.These graphite particles could be seen as dimples on the membrane surface, which led to a recurring optical abnormality.
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