(b)(4).The excor blood pump,s/n (b)(4), was in use by the patient from 2019-03-04 until 2019-05-17(74 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 been returned to the manufacturer yet.A detailed report will be submitted upon completion of the analysis.This report involves the right excor blood pump of the patient.The left side pump(serial number (b)(4))will be reported under 3004582654-2019-00054.
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