Results: a pipe cleaner was inserted into the pump max vacuum inlet and dried blood was observed inside the vacuum tubing.Conclusions: evaluation of the returned pump max confirmed blood was aspirated inside the vacuum pump.The reported complaint indicated that the aspiration tubing was directly connected to the vacuum inlet instead of the canister and blood was aspirated into the pump.If the aspiration tubing is connected to the vacuum inlet instead of the canister supplied by penumbra, fluid will likely be aspirated into the vacuum assembly and the pump may not function 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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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the aspiration tubing (tubing) was inadvertently connected directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max.However, the physician decided to use the same pump max to complete the procedure.There was no report of an adverse effect to the patient.
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