Results: there was no damage to the exterior of the penumbra system aspiration pump max 220 (pump).Corrosion was observed inside the pump piston cylinders.The pump inlet cylinder was severely corroded, and moisture was observed in the inlet cylinder head, as well as the inlet tubing and the tubing connecting the inlet cylinder to the outlet cylinder.Conclusions: evaluation of the returned device revealed that the pump was non-functional.The pump was plugged in and powered on.The cooling fan turned on, but no vacuum was generated.The penumbra investigator opened the pump and corrosion was found inside the cylinders.Further evaluation revealed moisture in the inlet cylinder head, as well as the inlet tubing and the tubing connecting the inlet cylinder to the outlet cylinder.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, fluid will likely enter the pump assembly, and may cause corrosion.This corrosion likely caused the piston to become seized, and prevented the pump from generating 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 220 (pump max).Upon attempting to turn on the pump max to begin aspiration with the penumbra system ace 68 reperfusion catheter (ace 68), the nurse noticed the pump max was unable to power on; therefore, the pump max was not used in the procedure.The procedure was completed using manual aspiration and the same ace 68.
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