BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBC FLOPUMP

    MDR report key: 5008472 · Received August 13, 2015

    Report

    Report Number
    1645362-2012-00002
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    June 6, 2012
    Report Date
    August 13, 2015
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT WAS RECEIVED ON 06/06/2012, AND THE DEVICE WAS RETURNED TO IBC FOR EVALUATION ON 07/25/2012. UPON RETURN, IT WAS CONFIRMED THAT THE PUMP HAD A LEAK. THE ROOT CAUSE WAS NOT ESTABLISHED, BUT IT IS POSSIBLE THAT AGGRESSIVE DEBUBBLING DURING THE PRIMING COULD HAVE CAUSED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT DURING CPB, THE PUMP HAD A LEAK. THIS REQUIRED THE PERFUSIONIST TO MAKE A SWITCH OF THE PUMP. THIS LED TO A COMPLICATION IN SURGERY AND PUT THE PATIENT AT RISK. THERE WAS NO INDICATION OF THE PATIENT CONDITION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534820 IBC FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORP. 6100S 100311-2186

    Patients

    Seq Age Sex Outcome Treatment
    1