BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAMAX

    MDR report key: 2963525 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00158
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    October 3, 2012
    Report Date
    March 28, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K991813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THERE WERE NO DISCREPANCIES FOUND IN THE MFG PROCESSES. THE RESULTS OF THE CHEMICAL TESTS, PERMEABILITY AND TIGHTNESS WERE FOUND TO MEET ALL SPECIFICATIONS. SINCE NO PRODUCT WAS RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED. FOLLOWING THE INVESTIGATION, OUR CONCLUSION IS THAT THE PROBABLE ROOT CAUSE IS UNK DUE TO NOT ENOUGH INFO OR THE AVAILABILITY OF THE DEVICE TO MAKE A DETERMINATION.

    Description of Event or Problem · 1

    AN ULTRAMAX GRAFT WAS IMPLANTED ON (B)(6) 2012. THE GRAFT WAS USED TO ENTER THE ARTERIAL CANNULA BUT WHEN THE HEART LUNG PERFUSION WAS STARTED, THERE WAS SEVERE AND CONSTANT BLEEDING FROM THE GRAFT, NOT THE ANASTOMOSIS, AS THE BLEEDING DID NOT STOP. THE ULTRAMAS GRAFT WAS REPLACED WITH A VASCUTEC AND THE BLEEDING STOPPED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570 ULTRAMAX DSY ATRIUM MEDICAL CORP. 23071 2114126383

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention