The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system aspiration pump max 220 (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 and it stopped working; therefore, the pump max was disconnected.The procedure was completed using another pump max.There was no report of an adverse effect to the patient.
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Results: a pipe cleaner was inserted into the vacuum inlet and blood was found inside the penumbra system aspiration pump max 220 (pump max) assembly.Conclusions: evaluation of the returned pump max confirmed fluid within the pump assembly.If the tubing is connected directly to the vacuum inlet, blood may be aspirated into the pump max.If fluid is aspirated into the pump max, the device may not function properly.Penumbra pumps are 100% 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.H3 other text : placeholder.
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