BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION

    MDR report key: 3966466 · Received June 25, 2014

    Report

    Report Number
    1721504-2014-00128
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND SEVERAL SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE BAG WAS PRESSURE TESTED AND FAILED THE PRESSURE TEST. THE FAILURE WAS ATTRIBUTED TO THE BOND BETWEEN THE TUBING AND THE BAG. THE COMPLAINT IS CONFIRMED. A SUPPLIER CORRECTIVE ACTION HAS BEEN REQUESTED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PRESSURE INFUSION BAG IS LOSING PRESSURE. THE LEAK WAS DISCOVERED BEFORE THE PROCEDURE BEGAN. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370547 PRESSURE INFUSION INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668545

    Patients

    Seq Age Sex Outcome Treatment
    1