The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (9 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.A detailed investigation report will be provided as soon as available pending return of the affected blood pump.
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The initial visual examination of the returned blood pump could not identify any defects, and no dimples were shown.The blood pump was then tested for functional performance where it met its required pumping specification.Dimples can be seen when the membranes are under pressure, because then the distance between the membrane layers is the smallest.Here the dimples could be confirmed and confirmed the customer complaint.The pump was then disassembled for further testing and the membrane layers were individually examined.All three membrane layers were found to be intact.Graphite agglomerates were detected between the membrane layers.These could be seen as dimples on the membrane surface.No membrane defect could be detected.The cause of the dimples noted on the membrane was most likely the graphite particles that formed due to an abrasion between the layers.The resulting graphite agglomerates led to a recurring optical abnormality.
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