BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNATIONAL BIOPHYSICS CORPORATION

    MDR report key: 3289349 · Received August 12, 2013

    Report

    Report Number
    MW5031429
    Event Type
    Injury
    Date Received
    August 12, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 5, 2013
    Manufacturer
    IBC
    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. NO SOURCE OF CIRCUIT ABNORMALITY. AIR OCCURRED IN BIO PUMP AGAIN. 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 WAS RETURNED TO THE MANUFACTURER FOR FOLLOW-UP EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386241 INTERNATIONAL BIOPHYSICS CORPORATION IBC FLOPUMP 6000 KFM IBC IBC FLOPUMP 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention