BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2043209 · Received February 24, 2011

    Report

    Report Number
    2026095-2011-00059
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 27, 2011
    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 REPORTED FILL VOLUME FOR THIS PUMP WAS 240ML. THE DIRECTIONS FOR USE (DFU) (1303046, REV. H) CONTAINS A CAUTION FOR UNDERFILLING THE PUMP: "CAUTIONS: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." A DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: FORTUM 9G) FAST FLOW. PUMP INFUSED IN 10 HOURS INSTEAD OF 24 HOURS. FILL VOLUME REPORTED WAS 240ML AT 10ML/HR. PUMP FILLED (B)(6) 2010. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010. 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 972581

    Patients

    Seq Age Sex Outcome Treatment
    1