Results: removal of the biohazard bags revealed blood on the pump housing.In addition, dried blood was found in and around the vacuum inlet on the top of the pump.A pipe cleaner was inserted in the pump inlet and blood was observed inside the pump.Conclusions: evaluation of the returned pump revealed blood in and around the pump vacuum inlet.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly.The observed blood likely contributed to the reported noise and the pump not producing vacuum.Penumbra pumps are visually and functionally inspected 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 220v (pump max).During the procedure, the pump max was powered on and a loud high-pitched noise was heard; however, the pump max did not produce any vacuum.Therefore, the procedure was completed by manual aspiration.There was no report of an adverse effect to the patient.
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