BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVARP PARACENTESIS PUMP

    MDR report key: 9824065 · Received March 12, 2020

    Report

    Report Number
    9824065
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 12, 2020
    Manufacturer
    GI SUPPLY, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE USED A RENOVA PARA KIT FOR A PARA AND THE TUBING WAS SPITTING OUT ASCITES FLUID LIKE THERE WAS A SMALL PUNCTURE IN THE TUBING. WE OPENED A NEW KIT AND DISCONNECTED THE PROBLEMATIC TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286642 RENOVARP PARACENTESIS PUMP PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA GI SUPPLY, INC. GIS-31 9063

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA