BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP

    MDR report key: 1830802 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00237
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA (B)(6) 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    AFTER THE HOSPITAL PERFORMED A CASE, THE NURSE WAS REPLACING THE FILTER ON THE ASPIRATION PUMP AND SHE DID NOT SCREW THE FILTER ON AT THE RIGHT ANGLE AND IT BECAME STUCK AND BROKE WHEN THEY TRIED TO REMOVE IT. THE WINDING BECAME LOOSE AND SEPARATED FROM THE PUMP.

    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