BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1310821 · Received February 5, 2009

    Report

    Report Number
    2026095-2009-00009
    Event Type
    Other
    Date Received
    February 5, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 9, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    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. THE SAMPLE HAS NOT BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. A REVIEW OF THE LOT HISTORY INDICATED IT WAS THE ONLY COMPLAINT FOR FAST FLOW FOR THIS LOT. THE DEVICE HISTORY RECORD WAS ALSO REVIEWED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOW RATE WAS TOO FAST. NO ADVERSE CLINICAL EFFECTS WERE NOTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORPORATION LT 270-54 812188

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other