BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 844631 · Received May 1, 2007

    Report

    Report Number
    MW1042770
    Event Type
    Malfunction
    Date Received
    May 1, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 1, 2007
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ECLIPSE DELIVERY SYSTEM - BY I-FLOW-, 50M1 SIZE, DELIVERS 50ML/HOUR. L0T 6B2754, EXP DATE 04-2009. PROBLEM: LEAKS FLUID OUT OF THE END OF THE ECLIPSE, OPPOSITE FROM THE TUBING CONNECTOR SITE. THIS HAS HAPPENED TO 10 OF THESE ECLIPSE "BALLS" IN THE LAST 5 WORKING DAYS, SAME LOT # AND EXP DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP ECLIPSE MEB I-FLOW CORP 50ML = 50ML/HR 6B2754

    Patients

    Seq Age Sex Outcome Treatment
    1 *