Results: dried blood was present on the pump max device housing.A pipe cleaner was inserted into the vacuum pump and blood was present.Conclusions: evaluation of the returned pump max revealed blood on the device housing and inside the vacuum pump.If the aspiration tubing is connected directly to the vacuum inlet instead of to the penumbra supplied canister, blood will likely enter the vacuum pump.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.
|
The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the hospital technologist accidentally connected the aspiration tubing (tubing) directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max during the first pass.Upon realizing the mistake, the tubing was reconnected to the canister.The procedure was successfully completed using the same pump max.There was no report of an adverse effect to the patient.
|