Lot number: 220308 or 220414.Expiration date: february 28, 2025 & march 31, 2025.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k): no:k071572, k130280.Device manufacture date: lot.220308: march 8, 2022 & lot.220414: april 14, 2022.Review of the manufacturing history record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination.The pump records were reviewed.Following information was found.Pre-oxygenator pressure and post-oxygenator pressure were compared.It was found that there was a period when post-oxygenator pressure was higher than pre-oxygenator pressure.When the flow rate was increased to approx.4.2 l/minute after the start of extracorporeal circulation, the pressure value increased in line with the increase in flow rate.At that time, the pressure loss (pre-oxygenator pressure - post-oxygenator pressure) was 7mmhg.A simulation test was performed using current product oxygenator, referring to the circulation condition during the time when the post-oxygenator pressure was higher than the pre-oxygenator pressure.Circulation conditions hb: 12g/dl, temperature 35°c, blood flow rate: 4.2l/minute pressure during circulation: pre-oxygenator pressure: 203mmhg, post-oxygenator pressure: 196mmhg the pressure loss when bovine blood flowed was measured referring to the data at the start of extracorporeal circulation.It was found that the pressure loss was 47mmhg, which was higher than the pressure loss when using the involved product.The pre-oxygenator pressure when bovine blood was passed through the oxygenator was confirmed so that the blood flow rate was 4.2l/minute and the post-oxygenator pressure was 196mmhg.It was found that it was 240mmhg, which was different from the pre-oxygenator pressure at the time of use the involved product.The post-oxygenator pressure when bovine blood was passed through the oxygenator was confirmed so that the blood flow rate was 4.2l/minute and the pre-oxygenator pressure was 203mmhg.It was found that it was 158mmhg, which was different from the post-oxygenator pressure at the time of use the involved product.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a cause of occurrence, since the actual product could not be confirmed and the conditions under which it was used could not be simulated, it was not possible to identify the cause.(b)(4).
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The user facility reported that the capiox device involved, pre-oxygenator pressure was lower than oxygenator exit pressure at priming.It was conceivable that inline pressure sensor (senko medical instrument) had a defect, so attempted to use the pressure sensor from the side branch of oxygenator, but the condition was the same.Then, considering the possibility of defect of the oxygenator, the oxygenator was replaced.The pressure change of the replaced oxygenator was the same as before the replacement.However, after the pump was turned on, the pressure became close to normal.This was an emergency case.The event occurred intra-operative.The patient was not injured, and medical or surgical intervention was not required.
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