BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX FLEXFLOW

    MDR report key: 1292858 · Received January 6, 2009

    Report

    Report Number
    1292858
    Event Type
    Malfunction
    Date Received
    January 6, 2009
    Date of Event
    January 3, 2009
    Report Date
    January 6, 2009
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AQUAPHORESIS BEGUN AND THE NEXT DAY THE TUBING WAS FOUND TO BE CRACKED AND BLOOD WAS PRESENT IN THE FILTER. TREATMENT WAS RESTARTED WITH A NEW TUBING/FILTER A FEW HOURS LATER. TWO HOURS FOLLOWING THE SECOND TUBING CHANGE THERE WAS AN ALARM REFLECTING PUMP FAILURE. TUBING/FILTER AGAIN FOUND TO BE CRACKED. PROCEDURE DISCONTINUED UNTIL THE FOLLOWING DAY WHEN COMPANY REP BROUGHT A NEW UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX FLEXFLOW AQUAPHORESIS THERAPY DEVICE KDI CHF SOLUTIONS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR