BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION MAX PUMP 110

    MDR report key: 3891146 · Received June 24, 2014

    Report

    Report Number
    3005168196-2014-00426
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THERE IS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE PUMP. CONCLUSION: THE PUMP WAS POWERED ON AND TESTED. THE VACUUM GAUGE APPEARS TO BE STUCK ON AT -4 IN HG EVEN WHEN THE KNOB IS ROTATED TO INCREASE AND DECREASE VACUUM PRESSURE. WHEN THE KNOB IS ROTATED TO INCREASE AND DECREASE VACUUM PRESSURE, THE CHANGE IN PRESSURE CAN BE HEARD FROM THE PUMP HOWEVER, THE GAUGE NEEDLE DOES NOT MOVE. VACUUM PRESSURE CAN ALSO BE FELT. THE PUMP IS NONFUNCTIONAL AS THE AMOUNT OF VACUUM CANNOT BE DETERMINED BY THE VACUUM GAUGE. THE COMPLAINT INDICATES THAT THE PUMP HAD NO VACUUM PRESSURE GENERATED BEFORE THE ASPIRATION TUBING WAS CONNECTED. IT ALSO STATES THAT THE VACUUM GAUGE WAS READING -5 IN HG. EVALUATION OF THE RETURNED PUMP CONFIRMED THAT THE VACUUM GAUGE IS NOT READING THE VACUUM PRESSURE CORRECTLY. IT APPEARS THAT THE PUMP IS WORKING, THERE IS VACUUM PRESSURE AND CHANGES IN PRESSURE CAN BE HEARD FROM THE PUMP HOWEVER, THE GAUGE DOES NOT REGISTER THE CHANGING PRESSURES. THE CAUSE OF THIS COMPLAINT MAY BE A MANUFACTURING DEFECT; HOWEVER THE ROOT CAUSE CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110. DURING DEVICE PREPARATION, THE TECHNICIAN NOTICED THAT THE PUMP WAS NOT GENERATING A VACUUM AND THE GAUGE ONLY READ -5 IN HG. THE PHYSICIAN DECIDED TO PERFORM MANUAL HAND ASPIRATION WHICH SUCCESSFULLY REMOVED THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368316 PENUMBRA ASPIRATION MAX PUMP 110 JCX JCX PENUMBRA, INC. F07760-41

    Patients

    Seq Age Sex Outcome Treatment
    1