BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6844771

    MDR report key: 6844771 · Received September 6, 2017

    Report

    Report Number
    6844771
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 14, 2017
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO MAINTAIN ORDERED DIALYSIS BLOOD FLOW RATE FROM MAHAKUR CVC. WITH THIS BRAND OF CVC, WHEN DOING HEMODIALYSIS, THE DIALYSIS STAFF HISTORICALLY HAVE NOT BEEN ABLE TO OBTAIN THE FLOWS NEEDED TO PERFORM TREATMENTS RESULTING IN PATIENT RECEIVING LESS THAN OPTIMAL HEMODIALYSIS. THE ORDERED BLOOD FLOW RATE WAS 250ML/MIN BUT THE CATHETER WAS ONLY ABLE TO OBTAIN BLOOD FLOW RATES OF 150ML/MIN. ADDITIONALLY, THERE WERE MULTIPLE ARTERIAL PRESSURE ALARMS.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DIALYSIS| PATIENT WAS UNDERGOING DIALYSIS.