BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 6705729 · Received July 12, 2017

    Report

    Report Number
    1645362-2017-00004
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    April 4, 2017
    Report Date
    July 11, 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

    PRODUCT WAS RETURNED AND EVALUATED, IT WAS DETERMINED THAT THE PRODUCT HAD A CRACK IN THE BASE ALONG THE SHAFT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN FILLING THE PRIMING CIRCUIT WITH PHYSIOLOGICAL SALINE SOLUTION, VERIFIED A CRACKING IN SURFACE OF THE PRODUCT. (NO CONTACT WITH THE PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489640 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 051016-4337 00814321020094

    Patients

    Seq Age Sex Outcome Treatment
    1