BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 7052714 · Received November 22, 2017

    Report

    Report Number
    1645362-2017-00006
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Report Date
    November 21, 2017
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    KFM
    UDI-DI
    00814321020094
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS BEEN RETURNED TO IBC. IT WAS DETERMINED THAT THERE WAS AN INTERAL LEAK IN THE DEVICE.

    Description of Event or Problem · 1

    IN THE FILL AND CIRCULATION OF THE PRIMING SOLUTION IT WAS OBSERVED AIR/ BUBBLES IN THE CENTRIFUGAL PUMP. STOPPED THE CIRCULATION, AND THE PERFUSIONIST SAW AIR ENTRANCE IN THE SIDE OF THE PRODUCT, WITHOUT LEAKING LIQUID. EXCHANGED FOR A NEW PRODUCT, CIRCULATED THE PRIME WITHOUT PROBLEMS. THERE WAS NO INJURY FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834175 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 070716-4449 00814321020094

    Patients

    Seq Age Sex Outcome Treatment
    1