BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V

    MDR report key: 6073821 · Received November 2, 2016

    Report

    Report Number
    3005168196-2016-01550
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548012773
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: DXE.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NRY.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) WAS OPENED BY PENUMBRA ENGINEERS AND CORROSION WAS OBSERVED ON THE PISTON CROWN IN THE OUTLET CYLINDER. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP WAS FUNCTIONAL. THE PUMP WAS PLUGGED IN, POWERED ON AND GENERATED VACUUM. THE PUMP HOUSING WAS REMOVED, AND THE VACUUM PUMP WAS OPENED BY PENUMBRA INVESTIGATORS. IT WAS OBSERVED THAT THE PISTON CROWN IN THE OUTLET CYLINDER WAS CORRODED. THE OBSERVED CORROSION LIKELY CAUSED THE PISTON TO SEIZE INSIDE THE CYLINDER, CAUSING THE PUMP TO FAIL TO GENERATE VACUUM. IT IS LIKELY THAT THE SEIZED PISTON BECAME FREED UP DURING TRANSIT TO PENUMBRA. THE CAT6 MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA PUMPS ARE 100% FUNCTIONALLY TESTED DURING INCOMING QUALITY INSPECTION. 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

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX WAS POWERED ON WITH THE GREEN LIGHT ILLUMINATED; HOWEVER, THE PUMP MAX DID NOT PRODUCE ANY VACUUM. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX AND THE SAME INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724759 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V DXE DXE PENUMBRA, INC. F22845-12 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR