The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.
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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 connected the aspiration tubing (tubing) directly to the pump max and consequently, blood was aspirated into the body of the pump max.The procedure was therefore completed using a different pump max.There was no report of an adverse effect to the patient.
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