Results: the penumbra system aspiration pump max 220v (pump) was plugged in and powered on.The pump generated full vacuum and, therefore, it was deemed functional.Further evaluation revealed the plastic cover for the on/off switch was separated from the pump housing and the piston crown in the outlet cylinder was corroded.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and generated full vacuum.The pump housing was removed, and the vacuum pump was opened by penumbra investigators.It was observed that the piston crown in the outlet cylinder was corroded.The observed corrosion likely caused the piston to seize inside the cylinder, causing the pump to generate vacuum.Further evaluation revealed the plastic cover for the on/off switch was separated from the pump housing.This damage was likely incidental and may have occurred during return packaging or shipment.Penumbra pumps are 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 220 (pump max).During the procedure, the physician attempted multiple times to begin aspiration, however the pump max was not producing any vacuum when powered on.The physician then changed the power cord, however the pump max was still unable to produce vacuum.Therefore, the procedure was completed using a syringe.There was no report of an adverse effect to the patient.
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