BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3823841 · Received February 21, 2014

    Report

    Report Number
    1721504-2014-00032
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 27, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE COMPLAINT DATABASE COULD NOT BE COMPLETED FOR LOT SPECIFIC INFORMATION. THE USER INDICATED THE AIR ENTERED THE SYSTEM AND WAS INJECTED INTO THE PATIENT AFTER THE CONTRAST WAS DEPLETED. MERIT IS UNABLE TO DETERMINE AN EXACT ROOT CAUSE WITHOUT THE ACTUAL DEVICE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AIR ENTERED THE SYSTEM WHEN THEY RAN OUT OF CONTRAST DURING A CORONARY ANGIOGRAPHIC PROCEDURE AND THEY DID NOT NOTICE. MICRO BUBBLES WERE INJECTED INTO THE PATIENT'S CORONARY ARTERY. THE PATIENT HAD NO SYMPTOMS AND DID NOT REQUIRE TREATMENT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109662 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening CONTRAST