The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max).During the procedures, the hospital staff noticed that the pump max was unable to remain powered on unless the power button was held down, and, additionally, it was noticed that the pump max was unable to create adequate suction, even when it remained on.The physician then found that the patient was already revascularized after receiving thrombolytic medication; therefore no mechanical thrombectomy was performed.There was no report of an adverse effect to the patients.
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The penumbra system aspiration pump max 220v (pump max) was plugged in and powered on; however, the power button would not stay depressed.However, the pump was able to reach full vacuum pressure.Evaluation of the returned device confirmed that the pump max power button would not stay depressed.The pump max was plugged in an attempted to be powered on; however, the power button would not stay depressed.In addition the pump max housing was cracked below the vacuum gauge and the pump max was able to create max vacuum pressure, while the power button was held down.The root cause of the button not remaining depressed could not be determined.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.Update on 23-aug-2017 for the supplier revealed that the received condition of the pump max housing (i.E.Crack located on the top housing, missing power button cover) indicates that the power button could have been a result of the pump being mishandled (dropped), thus causing the power button to be nonfunctional.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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