Results: dried blood and a crack were present on the device housing.A pipe cleaner was inserted into the vacuum inlet and blood was present.Conclusions: evaluation of the returned pump max confirmed a device with blood inside the vacuum pump.This is likely a result of the reported incorrect connection of the aspiration tubing directly to the vacuum inlet instead of the canister supplied by penumbra.If fluid enters the vacuum pump, it may prevent the pump from functioning properly.Penumbra pumps are visually inspected and functionally test 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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