Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no break or any other anomaly in the appearance.There was blood infiltrating the gas inlet and outlet sides.Since the tubes were in the open state, it was not possible to determine whether the blood leaked during use or leaked from the blood channel during return shipment.The actual sample after having been rinsed and dried, was filled with colored physiological saline solution, and then tested for leakage by air of 2kgf/cm2 being applied.No leak was observed, which inferred no anomaly that could lead to leakage such as cuts in the fiber.According to the results of the investigation, there was no cuts in the fiber and no leak was found.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Review of the performance test result confirmed that the involved fiber lot met the factory's specifications.Ifu states: do not use this product for a period in excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.It is likely that due to a change in the blood properties, a surface-active substance may occur in blood and disrupt the balance, which is maintained in the micropores of the fiber, between the surface tension of blood and the gas pressure.Such condition may lead to plasma leak.Especially in patients with renal or hepatic failure, the time to plasma leak tends to be short.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
|
The user facility reported the capiox custom pack was used during the procedure.About six hours after the start of cpb, a slight decrease in gas exchange performance was observed, so the oxygenator was checked visually, and a slight reddish liquid leakage was found from the side of the oxygenator.Since gas control could be achieved, the procedure was completed with the product.The procedure was completed successfully.The patient was not harmed.
|