Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Address: (b)(6) hospital.Occupation: clinical engineer.Pma/510(k)- k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Review of the shipping inspection record of the product in which the involved fiber lot was used confirmed that there was no anomaly in the gas exchange performance test and pressure drop test results.The test results satisfied the factory's control criteria.Ifu states: do not use this product for a period in the excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.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.It is likely that due to a change in the blood properties for some reason, a surface-active substance may be generated in blood.This may lead the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, and the fibers got hydrophilized, resulting in plasma leak; the pressure inside the oxygenator module raised by some factors, such as clotting, may cause the pressure applied from the blood channel to the gas channel to get increased.This may create the circumstances where force to push the blood corpuscle components out into the gas phase may increase and plasma component could easily leak out through the micro pores on the surface of the fibers to the gas channel.However with no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.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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