BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 6099878 · Received November 14, 2016

    Report

    Report Number
    1036844-2016-00594
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAS FOUND THE PSI'S HAVE BEEN CLOTTING OFF WHILE THE PERFUSIONIST IS TAKING ONE UNIT OF BLOOD BEFORE HEART CASE. THIS HAS BEEN OCCURRING SINCE (B)(6) 2016. THEY HAVE BEEN USING THIS LINE FOR OVER TEN YEARS WITHOUT A PROBLEM. NO OTHER FACTORS HAVE CHANGED. IN THE MOST RECENT CASE, THE LINE IS MUCH SLOWER TO FILL THE BAG AND REMAINING BLOOD IN TUBING AFTER BLOOD IS TAKEN. PERFUSIONIST STATED THE LINES FEEL DIFFERENT, ARE MORE RIGID, STIFF, AND THE FLOW RATE HAS DECREASED. THE TUBING ON THE LINE IS ALSO STIFFER AND COURSE. THERE HAVE BEEN DELAYS IN TREATMENT AND NO PATIENT DEATHS OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750824 PSI KIT: 8.5 FR INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1