The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (196 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 blood pump has not yet been returned to us.A follow-up report with the results of a detailed investigation will be provided as soon as available.This particular model is not available in the usa.However, a similar device is available, therefore, we are reporting under the mdr regulations.
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During the first visual examination of the returned blood pump, no abnormalities could be found.The pump was then disassembled for further testing and the membrane layers were individually tested.A small amount of graphite agglomerates were found in the membrane interstices.All three membrane layers were intact.During the production of excor blood pumps, graphite powder is applied to both surfaces of the air-side layer and middle layer, as well as to the surface of the blood-side layer which is not in contact with blood.During the pumping function when used on the patient, a small amount of graphite particles can detach from the surface of the membranes and visibly accumulate at the edge of the membrane interstices.Since the abnormality led to uncertainty for the customer, this complaint is classified as justified.
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