BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW ECLIPSE DISPOSABLE PUMP

    MDR report key: 829934 · Received March 16, 2007

    Report

    Report Number
    MW1042261
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 9, 2007
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    I-FLOW ECLISPE DISPOSABLE PUMP: WHEN FILLING DEVICE WITH SODIUM CHLORIDE 0.9% NOTICED EITHER GRAY PARTICULATE MATTER OR WHITE FLECKS IN THE SOLUTION. THE MATTER IS VERY HARD TO SEE IN SOME OF THE PUMPS. TWO LOTS WERE FOUND TO HAVE THIS PROBLEM (6A2377 3-09, C62769 5-09) SO THE DISTRIBUTOR SENT US A DIFFERENT LOT (712057 6-09) WHICH HAD THE SAME ISSUES OF WHITE FLECKS. I-FLOW THEN SENT US A DIFFERENT LOT FROM THEIR COMPANY DIRECTLY (712126 6-09) AND STILL FOUND WHITE FLECKS. ALL FILLED AND UNFILLED PUMPS OF THE 100ML SIZE @ 100ML/HR WERE RETURNED TO DISTRIBUTOR WHO WILL FORWARD TO I-FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ECLIPSE DISPOSABLE PUMP ELASTOMERIC 100 ML SIZE @ 100 ML/HR MEB I-FLOW * 6A2377
    2 I-FLOW ECLISPE ELASTOMERIC MFB I-FLOW * C62769
    3 I-FLOW ECLIPSE ELASTOMERIC MFB I-FLOW * 712057
    4 I-FLOW ECLIPSE ELASTOMERIC MFB I-FLOW * 712126

    Patients

    Seq Age Sex Outcome Treatment
    1 *