BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MAX PENUMBRA ASPIRATION PUMP 220

    MDR report key: 3882402 · Received June 18, 2014

    Report

    Report Number
    3005168196-2014-00403
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE PUMP, CANISTER, OR TUBING. THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT DESCRIBED SMOKE COMING FROM THE PUMP WHEN IT WAS SWITCHED ON DURING THE CASE. EVALUATION OF THE RETURNED DEVICE DID NOT REVEAL ANY PHYSICAL OR MECHANICAL ISSUE WITH THE PUMP. THE PUMP RAN FOR 30 MINUTES WITHOUT VISIBLE SMOKE OR A SMOKE SMELL. THE PUMP WAS FUNCTIONAL. THE CAUSE OF THIS COMPLIANT CANNOT BE DETERMINED. THE CANISTER KIT THAT WAS RETURNED WITH THE PUMP WAS NOT RELATED TO THE COMPLAINT AND WAS NOT DAMAGED. 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

    DURING A THROMBECTOMY PROCEDURE WHILE USING THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 IT WAS FOUND THAT WHEN TURNED ON, SMOKE BEGAN TO COME OUT OF IT. IT WAS IMMEDIATELY TURNED OFF AND THE PROCEDURE PROCEEDED WITHOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356871 PUMP MAX PENUMBRA ASPIRATION PUMP 220 JCX JCX PENUMBRA, INC. F07503-01

    Patients

    Seq Age Sex Outcome Treatment
    1