The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 110v (pump max).During the procedure, a hospital staff accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
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