BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 7881981 · Received September 17, 2018

    Report

    Report Number
    3005168196-2018-01831
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 19, 2018
    Report Date
    August 19, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012773
    PMA / PMN Number
    K160449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUMP MAX WAS POWERED ON AND GENERATED A VACUUM PRESSURE OF APPROXIMATELY -28.0 INHG. THE PUMP MAX WAS RUN CONTINUOUSLY FOR 15 MINUTES WITHOUT ISSUE. CONCLUSIONS: EVALUATION OF THE RETURNED PUMP MAX REVEALED A FULLY FUNCTIONAL DEVICE. THE PUMP MAX WAS POWERED ON AND ABLE TO GENERATE AN ASPIRATION PRESSURE WITHIN SPECIFICATION. THE PUMP MAX WAS RUN CONTINUOUSLY FOR 15 MINUTES WITHOUT ISSUE. PENUMBRA PUMPS ARE VISUALLY INSPECTED AND 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 IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, A PUMP MAX STOPPED WORKING. THEREFORE, THE PUMP MAX WAS TURNED OFF AND ON; HOWEVER, NO VACUUM WAS PRODUCED EVEN THOUGH THE GREEN INDICATOR LIGHT WAS ON. IT WAS REPORTED THAT THE PUMP MAX STARTED WORKING AGAIN ON ITS OWN RANDOMLY. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF A ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722240 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 NRY NRY PENUMBRA, INC. F34081-05 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR