This report is being submitted as follow up number 1 to provide the actual device evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the appearance.The actual device was rinsed dried and subjected to another visual inspection.There were no anomalies in the appearance.The actual device was circulated with bovine blood while ultra-filtrating performance and the pressure drop were determined.They results were confirmed to meet manufacturing specifications.There is no evidence that this event was related to a device defect or malfunction.The actual sample after having been rinsed and dried was verified to have normal performance in the pressure drop and the ultra-filtrating.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the dehydrating performance of the actual device was deteriorated due to the fibers being clogged.As a cause of the fibers being clogged, the below factors can be inferred experientially.Due to some factor(s), the flow rate of blood going into the actual device was decreased.By this, blood was concentrated excessively and clogged in the fibers.Blood concentrated due to administration of packed red blood cell or inflow of dehydrated blood was further concentrated when it flowed into the actual device and became clogged in the fibers.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: the capiox hemoconcentrator is designed to operate at flow rates within the range of 100 to 500 ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100ml/min blood flow may cause blood coagulation in the device.Stop using the hemoconcentrator if blood leakage, clotting or any other problem is observed.Replace it with a new one.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow of at least 50ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.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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