Results: dried blood was present on the device housing and was seen leaking from the air intake on the bottom of the device.Conclusions: evaluation of the returned pump max confirmed blood was present within the vacuum pump.This is likely result of the reported incorrect connection of the aspiration tubing directly to the vacuum inlet instead of the canister supplied by penumbra.If fluid is aspirated into the vacuum assembly, it may prevent the pump from functioning 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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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the hospital staff accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
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