Patient identifier: requested, unknown.Age & date of birth: requested, unknown.Patient sex: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no similar report on the involved product code/lot number.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.2243441.
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This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.Review of the provided video: the provided video showed that red transparent liquid was flowing out from gas-out side.Inspection of the actual sample: visual inspection of the actual sample upon arrival at the factory found that: there was no anomaly in the appearance such as a breakage.The entire oxygenation module had discolored to pink.Leak test: the actual sample was cleaned, the blood channel was filled with colored physiological saline solution, the blood outlet port side was blocked, and then air pressure of 2kgf/cm was applied from the blood inlet port.As a result, no leak was observed.According to the results of the investigation, there was no anomaly that could lead to leakage in the actual sample.As for the cause of this incident, since no leakage was observed during the investigation in the cleaned actual sample, the following possibility was considered based on our past experience.However, the cause of the plasma leak could not be clarified.The blood properties changed due to some factors and some substances possessing surfactant property was produced.Owing to such substances, the relationship of the surface tension between the blood and gas, which had been maintained in the micropores of the fiber, was broken, leading to the plasma leak.Ifu states: "a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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