BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP

    MDR report key: 1830771 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00201
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    August 7, 2007
    Report Date
    August 7, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE PUMP WAS TURNED ON AND MADE A LOUD RATTLING AND GRINDING NOISE. AFTER DISASSEMBLING THE PUMP, IT WAS FOUND THAT THE RATTLING SOUND WAS ORIGINATING FROM THE MOTOR AND PUMP INTERFACE. A RING METAL SHEET COVER BETWEEN THE MOTOR AND THE PUMP BECAME LOOSE AND WAS GRINDING AGAINST THE MOTOR GEARS WHICH GENERATED THE LOUD SOUND AND DAMAGED THE GEARS. CONCLUSION: THE METAL SHEET COVER IS "SNAPPED" FIT INTO A GROOVE IN THE BACK OF A PUMP. THE PUMP CANNOT BE USED DUE TO THE DAMAGE TO THE MOTOR SHAFT GEARS WHICH HAVE BEEN SHAVED BECAUSE OF CONTACT WITH THE RING METAL SHEET COVER. THIS COVER MAY HAVE NOT BEEN PROPERLY INSTALLED DURING THE MANUFACTURING PROCESS. THERE WAS NO LOOSE BOLT OR SCREW AS DESCRIBED IN THE INCIDENT. THIS ISSUE WAS COMMUNICATED TO THE PUMP VENDOR TO PREVENT FURTHER OCCURRENCES. (B)(4).

    Description of Event or Problem · 1

    WHEN THE PUMP WAS TAKEN FROM THE BOX AND TURNED ON IT MADE A VERY LOUD CLANGING NOISE AS IF A SCREW WAS LOOSE AND BOUNCING AROUND INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA ASPIRATION PUMP POWERED SUCTION PUMP BTA PENUMBRA, INC. 2008022615

    Patients

    Seq Age Sex Outcome Treatment
    1