BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    MDR report key: 7409141 · Received April 9, 2018

    Report

    Report Number
    3005168196-2018-00740
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 15, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012698
    PMA / PMN Number
    K160449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION TO SECTION: REUSE. THE POWER INLET WAS LOOSE. A POWER CONNECTOR WAS DISCONNECTED ON THE BACK OF THE POWER INLET. EVALUATION OF THE RETURNED PUMP MAX REVEALED IT WAS UNABLE TO POWER ON AND THE POWER INLET WAS LOOSE. IF THE PUMP IS DROPPED OR THE CORD IS FORCEFULLY BUMPED WHILE PLUGGED IN, THE POWER INLET MAY BECOME LOOSE. IF THE POWER CORD IS REPEATEDLY MANIPULATED OR ATTEMPTED TO BE REMOVED FROM A LOOSE POWER INLET, IT MAY PULL THE POWER INLET FROM THE HOUSING DETACHING A POWER CONNECTOR. IF THE POWER CONNECTORS BECOME DISCONNECTED THE PUMP WILL NOT POWER ON. PENUMBRA PUMPS ARE VISUALLY INSPECTED AND 100% 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

    SERIAL #: (B)(4). PRODUCT CODE (NRY), COMMON DEVICE NAME (NRY). DATE RECEIVED: 5/17/2018. 501(K): K160449.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, WHEN THE NURSE ATTEMPTED TO TURN ON A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX), THE PUMP MAX DID NOT TURN ON. THE PUMP MAX¿S ELECTRICAL PLUG WAS LOOSE AND DID NOT HAVE CONNECTION. THE DAMAGE WAS FOUND PRIOR TO USE AND THEREFORE, THE PUMP MAX WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE AND STENT RETRIEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252910 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 NRY NRY PENUMBRA, INC. F09147-50 00814548012698

    Patients

    Seq Age Sex Outcome Treatment
    1