BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT DENVER ASCITES DOUBLE VALVE

    MDR report key: 7125715 · Received December 18, 2017

    Report

    Report Number
    1625685-2017-00422
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 18, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    KPM
    PMA / PMN Number
    K011862
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE NOT RETURNED, NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    SYMPTOMATIC PATIENT WITH ASCITES. DENVER SHUNT, INSERTED IN 2017, NOT PUMPING. RADIOLOGIST CONCERNED ABOUT PUMP CHAMBER AND/OR VENOUS CATHETER BEING BLOCKED. ADVISED TO CHECK THAT THE PUMP CHAMBER AND VENOUS CATHETER ARE NOT BLOCKED. REPLACE WITH NEW DENVER SHUNT. DOUBLE-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906617 SHUNT DENVER ASCITES DOUBLE VALVE SHUNT, PERITONEAL KPM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other