Results: the pump was powered on for 30 minutes and functioned without an issue.There was no visible damage to the pump.Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was powered on for 30 minutes and functioned without an issue.The root cause of this complaint could not be determined.Pumps are 100% functionally tested during incoming 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 in the basilar artery using a penumbra system aspiration pump max 220v (pump max).During the procedure, after aspirating thrombus for approximately 20 minutes, the pump max unexpectedly stopped producing vacuum and the gauge read zero.The procedure was completed using a stent retriever.There was no report of an adverse effect to the patient.
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