The user facility reported a failure with the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: a terumo baby fx oxygenator failure 5 minutes after extracorporeal circulation (ecc), with blockage / occlusion / collapse of arterial oxygenator output; at full ecc during patient cooling from 37 °c to 32°c (water from the cooling / heating unit circulating at 30°c), total venous drainage observed without any oxygenated blood flow from the oxygen; complete impossibility of returning oxygenated blood to the patient was observed; act (+/- 10 minutes before the event) = 434 sec.; elective pediatric surgery to close cia + civ + debanding ap, cec machine - terumo system 1, gas monitoring online - cdi 500, dual - size tubes: 1/4 "- venous blood inlet, 3/16 "- venous blood outflow, 1/4 "- 3/16" - arterial pump, (b)(6) 2016 "- arterial blood outlet; checking the pre-bypass check list (service routine); preparation of priming (calculation according to the pediatric protocol of the service), and its circulation: o sodium bicarbonate, o mannitol 20%, or heparin, the fresh plasma, the plasma lyte; administered heparin and its control, act = 434 sec.; entering into ecc: arterial cannula = 12 fr and venous: vcs = 12 fr and vci = 16 fr.Vent catheterization and cardioplegia, with respective control and expurgation, respectively; start of patient cooling from 37°c to 32°c; first 5 minutes of ecc, no problem; impact: interruption of blood flow at the oxygen outlet with a period of low cardiac output, approximately 5 minutes, until the arterial circulation restored again; and it was reported there was no harm to the patient.
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The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies in the appearance.The actual device was rinsed, dried and subjected to another visual inspection.It was confirmed not to have any anomalies.The actual device was built into a circuit.Bovine blood hct35% and temperature 37°c was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the manufacturing specifications.Bovine blood was kept circulated through the device for 6 hours.No obstruction occurred.When the circulation was ceased, the actual device was flushed with water.No clot was found inside the actual device.On september 22, 2017 it was noted this device was also the same device reported in mdr 681834-2017-00199.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the actual device after having been rinsed was the normal product presenting no issue relating to obstruction.While the exact cause of the reported event cannot be definitively determined based on the available information that the patient was in the state of being cooled down and there was no issue in the gas transfer performance at the initial stage, it is likely the cold agglutination occurred and caused temporal obstruction in the actual device.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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