The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2020 (0 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 three layers, there are two more layers that will maintain the integrity of the air and blood chambers.The affected blood pump has not been returned to the manufacturer yet.A detailed investigation report will be provided as soon as it becomes available.
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During the initial visual examination of the returned blood pump, blood deposits were noted between the membrane layers.The pump was then disassembled for further testing and the membrane layers were individually tested.A defect in the blood-side layer of the triple layer membrane was detected.The defect was located directly opposite the de-airing port and corresponded in appearance to the shape and size of the de-airing cannula's tip.Based on the entry and exit points in the de-airing port, the direction of the entry canal for priming could be reconstructed and coincided with the damaged location in the blood-side layer.The air-side layer and the middle layer were found to be intact.A mixture of blood and dried blood particles were found between the blood-side layer and the middle layer.The thickness of the blood-side layer and the middle layer of the returned blood pump were re-measured at defined points.The thickness of the individual layers at all defined points and in the area around the leakage was found to be within specification at the time of the re-measurement.The cause of the defect is most likely an accidental puncturing of the blood-side layer of the triple layer membrane by the de-airing cannula during pump preparation.This led to a leakage in the blood-side layer.
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