The excor blood pump, s/n (b)(4) was in use by the patient from (b)(6) 2020 until (b)(6) 2020(161 days).We have reviewed the production records of the excor blood pump, s/n 1920588.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 it is available.
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During initial visual examination of the returned blood pump, no abnormalities were found.The blood pump was then tested for functional performance, where it did reach its required functional performance.The blood pump filled and emptied completely.Before further analysis, a ct scan was performed on the blood pump.All three layers of the three-layer membrane lie against one another, no air cushion was noted between layers.Particles can be seen between the membrane layers.A leak can be seen in the middle layer.The blood pump was disassembled for further testing and the membrane layers were individually examined.Two leakages were found in the middle layer of the triple layer membrane.The leakages in the middle layer are in the center of the membrane.Graphite agglomerates were found between the membranes.The air-side layer and the blood-side layer were found to be intact.The thickness of all three membrane layers was re-measured at the defined points.The thickness of the individual layers at all defined points was found to be within specification at the time of the re-measurement.The clinic also reported that the driving tube ran between the railings of the patients' bed.The surgeon removed and reconnected the driving tube from the ikus to take the patient to the operating room.After the driving tube was reconnected, the membrane gradually began to move again.It appears that driving tube may have been stuck (kinked) between the railings.This could be the reason why the video from the clinic showed that membrane of the blood pump does not move at all.Additionally, the clinic reported that when the membrane did not move, they got continuous "please check left pump and driving tube!" alarms from the driving unit, which would be generated in case of a defect in the diving unit or a kinked cannula.The cause of the leakages in the middle layer was most likely an abrasion between the membrane layers.This caused increased friction at some points, which finally led to the defect in the middle layer of the triple-layer membrane.The defect did not affect the functioning of the blood pump.
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