BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBC FLOPUMP 6000

    MDR report key: 4217286 · Received October 28, 2014

    Report

    Report Number
    MW5038888
    Event Type
    Injury
    Date Received
    October 28, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    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

    PRE-OPERATIVELY DURING PROCEDURE SET UP, THE FLOPUMP WAS PRIMED/DE-AIRED IN STANDARD FASHION FOR CARDIOPULMONARY BYPASS, WHILE RECIRCULATING AIR WAS NOTED IN THE FLOPUMP 6000 BIO PUMP. IT WAS DE-AIRED AND AIR WAS NOTED AGAIN. CIRCUIT WAS INSPECTED FOR POSSIBLE SOURCES OF AIR. PROPER PRIMING AND DE-AIRING TECHNIQUES WERE USED FOR SET UP. NO BANGING OR JARRING OF BIO HEAD. IT WAS REMOVED FROM CIRCUIT AND REPLACED WITH ANOTHER PUMP, THE REPLACEMENT PERFORMED AS DESIGNED. NO PATIENT PROBLEMS/EXPOSURE TO DEVICE IN QUESTION. THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR FOLLOW-UP EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689461 IBC FLOPUMP 6000 CARDIOPULMONARY BYPASS PUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION IBC FLOPUMP 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention