BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 5685313 · Received May 27, 2016

    Report

    Report Number
    1645362-2016-00002
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 27, 2016
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    KFM
    UDI-DI
    00814321020001
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS REJECTED BY THE CUSTOMER DURING RECEIVING INSPECTION AND WAS NOT USED ON A PATIENT. THE PUMP WAS INVESTIGATED UPON RETURN AND IT WAS CONFIRMED THAT SEVERAL CRACKS WERE PRESENT ON THE BASE OF THE PUMP.

    Description of Event or Problem · 1

    PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP CONTAINED CRACKS ON THE BASE OF THE PRODUCT. THIS WAS NOTICED DURING RECEIVING INSPECTION BY THE CUSTOMER AND NOT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340554 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 080615-3659 00814321020001

    Patients

    Seq Age Sex Outcome Treatment
    1