The involved device was returned to the user facility for evaluation.Visual inspection upon receipt did not find any visible break on it.Red thrombus was found to have formed in the lower part and the lateral part of the cr filter and around the blood outlet port.The reservoir was disassembled for further inspection.The cr filter was rinsed off with saline solution.Visual inspection of the cr filter and the de-bubbling material inside the cr filter found the adhesion of red thrombus on their insides and outsides.It was also found that membrane-like red thrombus had been formed all over the inside surfaces.Neither the cr filter nor the de-bubbling material were revealed to have any visible breaks.Electron microscopic evaluation of the cr filter, focusing on the segment where red thrombus had formed, revealed the adhesion of blood corpuscles, including red and white blood cells and the formation of fibrin net.Electron microscopic evaluation of the de-bubbling material, focusing on the segment where red thrombus had formed revealed the adhesion of blood corpuscles, including red and white blood cells and the formation of fibrin net.The cr filter and the de-bubbling material were further rinsed and inspected under electron microscope.No anomalies were revealed.The venous filter and the de-bubbling material set inside the venous filter were taken out of the actual sample and rinsed with saline solution for further visual inspection.Red thrombus was found to have formed on the outside surface of the venous filter.There were no visible formation of red thrombus on the inside surface of the venous filter or the inside and outside surfaces of the de-bubbling material.Neither the venous filters nor the de-bubbling material revealed any visible breaks.Electron microscopic evaluation of the venous filter, focusing on the segment where red thrombus had formed revealed adhesion of blood corpuscles, including red and white blood cells or the formation of fibrin net.The venous filter and the de-bubbling material were further rinsed and inspected under electron microscope.No anomalies were revealed.A review of the involved pump record did not find any increase in the pressure drop during the procedure or any factor which would have contributed to the thrombus formation.A review of the device history record of the involved product/lot number combination was conducted with no relevant findings.The customer reported a similar event for a capiox device.See mdr number 9681834-2016-00036 for details.There is no evidence that this event was related to a device defect or malfunction.Based upon the available information, it is likely that coagulated blood may have been suctioned into the reservoir, resulting in the reported thrombus formation.The definitive cause of this complaint, however, cannot be determined.(b)(4).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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The user facility reported a clog in the capiox device.Follow up communication with the user facility confirmed the following information: in a cabg case, before the weaning, blood frothed out of the cardiotomy filter.The pressure inside of the reservoir became positive and blood flowed backward into the soft bag containing saline solution connected to the reservoir.Beriplast was concurrently used.The procedure was completed successfully.The patient was not harmed.
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