BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1943589 · Received December 8, 2010

    Report

    Report Number
    2026095-2010-00298
    Event Type
    Other
    Date Received
    December 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR THE EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO DETERMINATION CAN BE MADE AS TO WHY THE PUMP APPEARED TO INFUSE QUICKLY. THE DIRECTIONS FOR USE (DFU) (1303046, REV. G) TABLE 1 NOTES THAT THE MINIMUM FILL VOLUME FOR THIS PUMP IS 150ML. THE REPORTED FILL VOLUME WAS 255ML SHOULD FLOW APPROX 48 HOURS. THE DFU ALSO CONTAINS A CAUTION STATEMENT: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. NO ADVERSE EVENT OCCURRED. IN ADDITION, THE DFU STATES THAT THE DELIVERY TIMES ARE APPROXIMATELY, AND HAVE AN ACCURACY OF +/- 15% WHEN PUMP IS FILLED TO NOMINAL. THE DEVICE HISTORY RECORD FOR THE ABOVE LOT WAS REVIEWED. ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO CONFIRMED COMPLAINTS FOR FAST FLOW FOR THE REPORTED LOT. IF ADDITIONAL INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, THE FILE WILL BE REOPENED.

    Description of Event or Problem · 1

    FAST FLOW. CUSOTMER DID NOT WAIT THE 4 HOURS AFTER FILLING BEFORE USE, AS REQUIRED BY THE DIRECTIONS FOR USE. PT EXPERIENCED A HEADACHE AND DIZZINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. ST 400-4 012451

    Patients

    Seq Age Sex Outcome Treatment
    1