BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP

    MDR report key: 1830849 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00253
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    November 15, 2008
    Report Date
    November 20, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    AT THE START OF THE STROKE PROCEDURE, WHILE TRYING TO HOOK UP THE FILTER TO THE PUMP, THE PHYSICIAN NOTICED THAT THE NUT WAS LOOSE ON THE PUMP AND THAT THERE WAS MINIMAL ASPIRATION. THE OTHER PUMP WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA ASPIRATION PUMP POWERED SUCTION PUMP BTA PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1