The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max) and a penumbra system ace 68 reperfusion catheters (ace68).During the procedure, the pump max aspiration pressure would not increase beyond -20 inhg resulting in the decrease of suction force for the thrombus; therefore, the pump max was removed.It was reported that multiple attempts were made to troubleshoot the pump max but were unsuccessful.The procedure was completed using manual aspiration with a 60cc syringe.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 observed inside the tubing.Conclusions: evaluation of the returned pump max revealed blood within the tubing.If the aspiration tubing is connected directly to the vacuum inlet instead of a canister, supplied by penumbra, blood may be aspiration into the pump assembly.If this occurs, the pump max 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.
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