The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no anomalies in the appearance.The comparative pressure drop test was conducted.The actual sample and a current product sample were circulated with saline solution while the pressure drop was determined.The actual sample was found to have a higher pressure drop, indicating that the actual sample became clogged.Visual inspection found that clots had formed on the blood inlet side and on the blood outlet side.The actual device, after having been rinsed and dried, was circulated with bovine blood, while ultrafiltrating performance and the pressure drop were determined.They were confirmed to meet manufacturing specifications.A review of the device history record of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined based on the available information, it is likely that the dehydrating performance of the actual sample was deteriorated due to the fibers being clogged.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "the capiox hemoconentrator is designed to operate at flow rates within the range of 100 to 500ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100 ml/min blood flow may cause blood coagulation in the device." "do not exceed 50% hematocrit at the blood outlet during ultrafiltration." and "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." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
|