BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2043334 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00046
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    April 10, 2008
    Report Date
    June 30, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT 772074 HISTORY FOUND NO CONFIRMED COMPLAINTS OF FAST FLOW FOR THE LOT REPORTED. I-FLOW RECEIVED ONE EMPTY AND USED SAMPLE FOR EVALUATION AND INVESTIGATION. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE FILL VOLUME OF 60ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW RATE ACCURACY WAS WITHIN SPECIFICATION. IN ADDITION, RETAIN SAMPLES FROM LOT 772074 WERE TESTED. THE PUMPS WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 60 ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW ACCURACY TEST RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. PRODUCT COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: SANDOSTATINE 300 NG 30ML + 30ML OF NACL). FLOW RATE TOO FAST. (FILL VOLUME: 60ML AND FLOW RATE: 2ML/HR). INFUSED IN 16 HOURS INSTEAD OF 24 HOURS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION LT 60-24 772074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK