The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max).During the procedure, the hospital staff noticed that the pump max turned on, but did not aspirate.In addition, the pump max had blood inside, but it did not smoke.The procedure was completed successfully using a new 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 on the pump max and blood was observed inside the pump.There was fluid inside the pump vacuum assembly.No functional testing was performed.Conclusions: evaluation of the returned pump max revealed there was blood present inside the vacuum assembly.This is most likely a result of incorrectly connecting the aspiration tubing directly to the pump max vacuum inlet rather than the canister supplied by penumbra.This likely allowed blood to enter the pump assembly.If fluid is aspirated into the pump max, 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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