The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, the physician completed the first pass using the pump max.While attempting to perform the second pass, no vacuum was observed and the pressure gauge needle did not move.Therefore, the pump max was disconnected and the procedure was completed using a manual aspiration with a syringe.There was no report of an adverse effect to the patient.
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Results: dried blood was present inside the vacuum inlet nozzle.Conclusions: evaluation of the returned penumbra system aspiration pump max 220v (pump max) revealed dried blood was inside the vacuum inlet nozzle.If the aspiration tubing is connected directly to the vacuum inlet nozzle instead of the canister supplied by penumbra, blood will likely be aspirated into the vacuum assembly.If fluid is aspirated into the vacuum assembly, the pump may not function properly.Penumbra pumps are visually inspected 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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