Results: a pipe cleaner was inserted into the vacuum inlet and blood was observed inside the pump max.The pump max had blood inside and, therefore, the pump was not functionally tested.Conclusions: evaluation of the returned pump max revealed blood inside the vacuum pump assembly.This is likely a result of the reported incorrect connection of the aspiration tubing directly to the pump max vacuum inlet instead of the canister supplied by penumbra.This will allow blood to enter the vacuum pump assembly.If fluid enters the vacuum pump assembly, it may prevent the pump from functioning properly.Penumbra pumps are visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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