On (b)(6) 2016 09:15 am (gmt-5:00) added by(b)(6) ((b)(4)): (b)(4).Blood leakage from the gas outlet is a known failure mode for quadrox-i adult without filter oxygenator and is identified in the risk assessment.Capa was implemented.This failure mode, also known as fiber leakage, is due to fiber breakage and results in blood leaks from the blood side to the gas side where, due to gravity, blood collects at the lowest point of the oxygenator either at the gas outlet opening or holder port.The fiber breakage is caused by cold creeping of the fibers resulting in a very slight change in the length of the fiber.Cold creeping is a natural effect of the (b)(4) fibers used in these oxygenators and occurs as the product ages.Important fiber characteristics were identified by research and were agreed upon, documented and controlled by the fiber supplier.The supplier extrusion process was reviewed and no systematic errors were identified.The supplier of the microporous fibers has established in-process controls.The maquet process for tempering of complete housing was also analyzed and counter checked by an external tempering experiment.The experiment revealed no probable process or design faults in regards to broken fibers.The maquet final tightness test was verified with master samples and approved as precise enough to detect broken fibers during the maquet manufacturing process.The described defect of leaking oxygenators will continue to be tracked and trended.With the implementation of spc (statistical process control) at the receiving inspection and controls, the risk is mitigated to as ¿as low as reasonably possible¿.
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