BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 3955407 · Received July 24, 2014

    Report

    Report Number
    3005168196-2014-00472
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 25, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: IT IS UNKNOWN IF THIS DEVICE IS AVAILABLE FOR RETURN. IF THE DEVICE IS MADE AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEREBRAL ARTERY USING THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110. DURING THE PROCEDURE, AS THE PHYSICIAN TURNED ON THE PUMP MAX 110, THE MOTOR SOUND BEGAN, BUT THE METER SHOWED A ZERO PRESSURE AND IT WOULD NOT ACHIEVE VACUUM. THE PHYSICIAN RESTARTED THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110, AND IT BEGAN WORKING AS INTENDED UPON TURNING IT ON. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT. THE PHYSICIAN STATED THAT THIS WAS NOT THE FIRST TIME THE ISSUE OCCURRED WITH THIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433624 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX JCX PENUMBRA, INC. F07195-01

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR