BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 5410359 · Received February 4, 2016

    Report

    Report Number
    1645362-2016-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    November 16, 2015
    Report Date
    February 4, 2016
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS INVESTIGATED UPON RETURN PER (B)(4). BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE BEARINGS OF THE PUMP WERE AFFECTED BY THE PRESENCE OF BLOOD WITHIN THE BEARINGS. THE CAUSE FOR THIS IS NOT KNOWN, HOWEVER, IT IS POSSIBLE THAT THE PUMP WAS DAMAGED DURING SHIPPING/TRANSPORT/PRIMING. IT IS ALSO POSSIBLE THAT THE SHAFT OF THE PUMP WAS WOBBLING DUE TO SMALL CRACKS WHICH WERE EVIDENCED IN THE PLASTIC BASE, WHICH COULD HAVE LED TO LEAKING INTO THE BEARING AREA.

    Description of Event or Problem · 1

    PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP EVIDENCED AN UNUSUAL NOISE AND LACK OF MINIMAL ROTATION AND REQUIRED REPLACEMENT DURING PROCEDURE. THE CUSTOMER COMPLAINT WAS RECEIVED BY IBC ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69246 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 112014-3281 00814321020094

    Patients

    Seq Age Sex Outcome Treatment
    1