The penumbra system aspiration pump max 110v (pump max) regulator knob lock nut was not locked, and the regulator knob assembly rotated freely.Evaluation of the returned pump max revealed that the regulator knob lock nut was loose.The pump max generated full vacuum, but was difficult to adjust due to damaged regulator knob.If the regulator knob is rotated beyond the intended limit, the washer may lose grip and cause the hex nut to back out.Penumbra pump maxs are visually and functionally inspected 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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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the laboratory staff noticed that the pump max vacuum regulator dial was loose.Although this was noticed at the beginning of the procedure, the physician successfully completed the procedure using the same pump max.It was noted the pump max functioned normally at full aspiration for the duration of the procedure.There was no report of an adverse effect to the patient.
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