BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1583369 · Received January 14, 2010

    Report

    Report Number
    2026095-2010-00004
    Event Type
    Other
    Date Received
    January 14, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 16, 2009
    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

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO CONFIRMED COMPLAINTS FOR FAST FLOW FOR THE REPORTED LOT NUMBER. NO DETERMINATION COULD BE MADE AS TO WHY THE PUMP APPEARED TO FLOW FAST. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FLOW RATE TOO FAST. INFUSION COMPLETED IN 24 HR INSTEAD OF 48 HR. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORPORATION LT 100-48 912838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other