Results: the penumbra system aspiration pump max 110v (pump max) was opened by the penumbra investigator and no damage or abnormalities were observed.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was plugged in and powered on and aspiration was present.The vacuum was fully adjustable and, therefore, functional.The pump was opened by the penumbra investigator and no damage or abnormalities were observed.The root cause of this complaint could not be determined.Pumps are 100% functionally tested during in-process 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 110v (pump max).During the procedure, while the pump max was being used to aspirate clot, it was noticed that the pump max was not making any noise and had also stopped aspirating.The pump max started working normally again after it was powered off and back on.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
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