BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2043333 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00051
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    August 25, 2008
    Report Date
    September 17, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU): FILLING THE PUMP LESS THAN NOMINAL RESULTS IN A FASTER FLOW RATE. THE DFU ALSO INDICATES THAT WHEN FILLED TO NOMINAL VOLUME, EASYPUMP LT FLOW RATE ACCURACY IS +/-15% OF THE LABELED FLOW RATE WHEN INFUSION IS STARTED 0-8 H AFTER FILL AND DELIVERING NORMAL SALINE AS THE DILUENT AT 31 DEGREES C/88 DEGREES F AGAINST A BACK PRESSURE OF 40CM OF WATER. A DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY SHOWED NO OTHER COMPLAINTS FOR FAST FLOW FOR THIS LOT. I-FLOW RECEIVED TWO EMPTY AND USED PUMPS FOR EVALUATION AND INVESTIGATION. THE PUMPS WERE REFILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 250ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE PUMPS WERE FOUND TO MEET SPECIFICATION. RETAIN SAMPLES FROM LOT 772093 WERE EVALUATED AND MET SPECIFICATION. WE REVIEWED OUR DEVICE HISTORY RECORD, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW.

    Description of Event or Problem · 1

    (DRUG/DILUENT: FORTUM 4GR). FLOW RATE TOO FAST. INFUSED IN 12 HOURS INSTEAD OF 24 HOURS. FILL VOLUME 250ML AND FLOW RATE 10ML/HR. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008. PER DFU: NOMINAL FILL VOLUME: 270ML AND NOMINAL FLOW RATE: 10ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION LT 270-24 772093

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR