BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP 6000

    MDR report key: 3492268 · Received November 22, 2013

    Report

    Report Number
    MW5033111
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 21, 2013
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SETUP FOR THE CARDIAC PROCEDURE, THE FLOPUMP WAS PRIMED AND DE-AIRED IN THE STANDARD FASHION. PRIOR TO INITIATION OF CARDIOPULMONARY BYPASS A SMALL AMOUNT OF AIR WAS NOTED IN THE PUMP. THE AIR WAS REMOVED FROM THE FLOPUMP, IT WAS VISUALLY INSPECTED AND NO SOURCE FOR THE AIR COULD BE SEEN AND THE PUMP WAS DEEMED SUITABLE FOR BYPASS. THE BYPASS PROCEDURE WAS COMPLETED WITHOUT EVENT, BUT FOLLOWING THE PROCEDURE (AFTER TERMINATION OF BYPASS, DURING TEAR-DOWN) THE FLOPUMP WAS INSPECTED AGAIN AND THERE SEEMED TO BE FLUID/BLOOD IN THE INTERNAL COMPARTMENTS OF THE PUMP WHERE THE BEARINGS AND MAGNET ARE HOUSED. NOT KNOWING IF THIS WAS THE EXACT CASE, BUT FEELING LIKE IT SHOULD BE INSPECTED; THE PUMP WAS REMOVED FROM THE CIRCUIT AND PREPARED TO BE RETURNED TO THE MANUFACTURER FOR INSPECTION AND TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608330 FLOPUMP 6000 FLOPUMP 6000 KFM INTERNATIONAL BIOPHYSICS CORP FLOPUMP 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR