During preparation for a thrombectomy procedure, the hospital staff noticed that the regulator knob of a penumbra system pump max 110v (pump max) was broken.Although the reported issue was found prior to use and prior to the patient being on the table, the pump max was used in the procedure.During the procedure, the pump max produced low vacuum.The procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
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Results: the regulator knob was loose from the pump housing.Conclusion: evaluation of the returned pump max revealed that the regulator knob was loose from the pump housing.If the regulator knob is over-tightened during use, the regulator knob may become loose.The loose regulator knob may contribute to difficulty regulating vacuum pressure.During functional testing, the regulator knob was able to regulate vacuum pressure.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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