The patient was undergoing a thrombectomy procedure treating an occluded stent graft popliteal using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max was switched on; however, no vacuum was produced.It was reported that the pump max emitted a bad smell.Therefore, the procedure was completed by manual aspiration using other aspiration catheters.There was no report of an adverse effect to the patient.
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Results: there was no visible damage to the exterior of the pump.Conclusions: evaluation of the returned pump confirmed that when the pump was powered on, the pump would not produce any vacuum.The pump was returned to the supplier for further evaluation.The pump was opened by the supplier and corrosion was observed on the outlet cylinder piston crown.The corrosion likely caused the piston to seize, and prevented the pump from generating vacuum pressure.Penumbra pumps are visually and 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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