BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 7079838 · Received December 4, 2017

    Report

    Report Number
    1645362-2017-00008
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 1, 2017
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE TO RETURN FOR EVALUATION.

    Description of Event or Problem · 1

    PUMP WAS ORIGINALLY PRIMED ON FRIDAY (B)(6) 2017. IT WAS NOT USED THEN. ON MONDAY (B)(6) 2017, DISCARDED CIRCUIT. LEAKING FROM BOTTOM/CENTER OF CONE. APPEARED TO HAVE A DIME SIZE CRACK AT THE CENTRAL "SHAFT" AREA. (NO CONTACT WITH THE PATIENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858351 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 033016-4219

    Patients

    Seq Age Sex Outcome Treatment
    1