BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1031776 · Received April 18, 2008

    Report

    Report Number
    2026095-2008-00047
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 19, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLES WERE RECEIVED FOR EVAL AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND THE EVAL OF THE SAMPLES. RECEIVED TWO EMPTY AND USED PUMPS AND ONE PARTIALLY FULL PUMP FOR EVAL AND INVESTIGATION. THE PUMPS WERE REFILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 270ML AND A FLOW ACCURACY TEST WAS PERFORMED. ONE PUMP FLOW RATE WAS WITHIN SPECIFICATION. TWO PUMPS RAN AT A SLIGHTLY HIGHER FLOW RATE THAN SPECIFICATION. AN EVAL IS BEING CONDUCTED TO DETERMINE THE ROOT CAUSE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 762913, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF LOT HISTORY FOUND NO OTHER FAST FLOW COMPLAINTS FOR LOT 762913. IN ADDITION, RETAIN SAMPLES FROM LOT 762913 WERE TESTED. THE PUMPS WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 270ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW ACCURACY TEST RESULTS WERE FOUND TO BE SLIGHTLY HIGHER THAN SPECIFICATION. PRODUCT COMPLAINT IS CONFIRMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORP. LT-270-24 762913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other