Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection revealed that no damage or other anomalies leading to pressure drop.The actual sample was rinsed, the blood channel was filled with normal saline (colored for better visibility), the blood outlet port was occluded, and then air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.As a result, no leak occurred.The actual sample was built into a circuit with tubing, and then the pressure loss was measured while bovine blood (hct 35%, temp.37°c) was circulated at each flow rate.The results were within the manufacturers specifications, and no anomaly was found that would lead to a pressure drop.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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