BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1062395 · Received June 18, 2008

    Report

    Report Number
    2026095-2008-00060
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 20, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND THE EVALUATION OF THE SAMPLE RETURNED. THE INFO PROVIDED INDICATED THAT THE PUMP INFUSED TOO QUICKLY. THE PT REPORTED VOMITING, HYPERTHERMIA, AND TIREDNESS. THE DEVICE INVOLVED IN THIS COMPLAINT WAS RECEIVED AND EVALUATED. THE FLOW RATE ACCURACY TEST WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE LOT WAS RELEASED PER SPECIFICATION. RETAIN SAMPLES FROM LOT 772119 WERE ALSO EVALUATED FOR FLOW RATE. THE FLOW RATE ACCURACY TEST WAS FOUND TO BE WITHIN SPECIFICATION. NO PROBLEMS WERE IDENTIFIED WITH THE DEVICES EVALUATED. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    FLOW RATE TOO FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORPORATION 04434370 772119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other