Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and corrosion was present on the piston crown of the outlet cylinder.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and generated fully adjustable vacuum.The pump was opened by the penumbra investigator.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, preventing the pump from functioning.The root cause of this corrosion could not be determined.Penumbra pumps are 100% 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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During preparation for a thrombectomy procedure, while testing a penumbra system aspiration pump max 110v (pump max), the technologist noticed that when the pump max was switched on, the green on/off button illuminated; however, the pump did not run and the motor did not come on.The technologist then hit the back of the pump max a couple of times and it started up and ran fine.The procedure was completed using the same pump max.
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