Returned part (SN 592786-0092) was visually inspected and no damaged component was identified.

A subsequent dye-leak test on blood side was carried out to verify the integrity of the device.

The unit was filled with methylene blue and pressurized by sealing all the outlet ports, in line with the maximum internal pressure value permitted in blood path (1 Bar) as per product specifications.

The internal pressure value was kept monitored with a pressure gauge connected to the circuit at the level of the inlet.

In the early filling phase, the inner core of oxygenator fiber bundle was found to be broken (it turned blue) and spillage of dye solution from open slot region of the device was reproduced.

Based on observed findings, reported failure was confirmed and traced back to damaged fiber/s of the oxygenator module.

In such a case, fluid (priming or blood) enters into the ruptured capillary and leaks out of gas escape compartment following gas flow direction.

Considering that 100% of the units in production line is subjected to final leak test and that involved unit successfully passed the in-process check and no trend has been registered for similar cases, it cannot be excluded that fiber bundle capillary manufacturing variability with contribution of sterilization thermal and/or transportation mechanical stress could have led to breakage during use.

No specific action is currently deemed as necessary.

LivaNova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.

‍