Results: the image of the serial number on the back of the penumbra system aspiration pump max 110 (pump max) was evaluated.The tubing to the regulator knob was twisted.Conclusion: evaluation of the returned pump max revealed that the regulator knob was damaged.The pump max was plugged in and powered on.While adjusting the vacuum pressure using the knob, the pressure was unable to be increased and decrease; however, once the knob was turned to maximum vacuum pressure the knob sprung towards the opposite direction.The pump max housing was removed by the penumbra investigator and it was observed that the tubing to the regulator knob was twisted.The tubing being twisted likely created the springiness that was felt during preparation.The kinked tubing also prevented the vacuum pressure from being adjusted during the functional analysis.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.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 110 (pump max).During preparation for the procedure, the hospital staff found that the regulator knob of the pump max felt ¿springy¿, and when turned to maximum aspiration the knob had a tendency to turn in the opposite direction.The pump max was therefore not used, and the procedure was completed using a new pump max.There was no report of an adverse effect to the patient.
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