BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1943758 · Received December 17, 2010

    Report

    Report Number
    2026095-2010-00313
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 24, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    FAST FLOW. PATIENT NOTICED THAT 1.5 HOURS AFTER ATTACHING THE PUMP, TWO MUCH INFUSION HAD BEEN DELIVERED. FILL VOLUME REPORTED OF 65 IS WELL BELOW MINIMUM FILL VOLUME OF 155ML FOR THIS 270ML PUMP. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION LT 270-270 992896

    Patients

    Seq Age Sex Outcome Treatment
    1