BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEPUMP

    MDR report key: 1914453 · Received November 22, 2010

    Report

    Report Number
    2026095-2010-00288
    Event Type
    Other
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 29, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PUMP INFUSED VERY FAST, IN ABOUT 25 HRS INSTEAD OF 46 HRS. PT FELT DIZZY. DATE OF EVENT: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION C270050 982668

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other