BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V

    MDR report key: 6041225 · Received October 19, 2016

    Report

    Report Number
    3005168196-2016-01472
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP MAX) HOUSING WAS OPENED AND CORROSION WAS FOUND ON THE PISTON CROWN AND AROUND THE PISTON CYLINDER. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP MAX WAS NONFUNCTIONAL. THE PUMP MAX WAS PLUGGED IN AND POWERED ON AND NO VACUUM WAS OBSERVED. FURTHER EVALUATION OF THE PUMP MAX REVEALED THAT CORROSION WAS LOCATED ON THE PISTON CROWN AND INSIDE THE PISTON CYLINDER. THE CORROSION LIKELY CONTRIBUTED TO THE PUMP MAX NOT PRODUCING ANY VACUUM DURING THE PROCEDURE. PENUMBRA PUMP MAXS ARE FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION TO SECTION: MANUFACTURE DATE: 3/18/2014.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DXE, COMMON DEVICE NAME: DXE. 510K: K160533. ADDITIONAL INFORMATION: LOT #: F11347-41, SERIAL #: (B)(4), UNIQUE IDENTIFIER: (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY , THE PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP MAX) WAS NOT PRODUCING VACUUM WHEN TURNED ON. IT WAS REPORTED THAT THE PUMP MAX WAS ONLY MAKING THE FAN NOISE BUT NOT THE TYPICAL "PUMPING" NOISE. THE ISSUE WITH THE PUMP MAX WAS NOTICED PRIOR TO USE AND THEREFORE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING MANUAL ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693058 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V DXE DXE PENUMBRA, INC. F11347-41

    Patients

    Seq Age Sex Outcome Treatment
    1