BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 5842223 · Received August 2, 2016

    Report

    Report Number
    1645362-2016-00006
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    May 2, 2016
    Report Date
    August 2, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRIMING, IT WAS NOTED THAT THERE WAS AN UNUSUAL SOUND FROM THE PUMP. THE PUMP WAS REPLACED AND SURGERY PROCEEDED. UPON RETURN, THE PUMP WAS INVESTIGATED AND IT WAS DETERMINED THAT THERE WERE SEVERAL CRACKS IN 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 PRIMING OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494082 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 092415-3781 00814321020094

    Patients

    Seq Age Sex Outcome Treatment
    1