BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OKAY II

    MDR report key: 20356148 · Received October 2, 2024

    Report

    Report Number
    3007835716-2024-00253
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 10, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    DTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. AS A RESULT OF THE INVESTIGATION, THERE WERE NO ABNORMALITIES IN THE FUNCTIONALITY OF THE RETURNED PRODUCT. IT IS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY AIR GETTING DUE TO AIR REMAINING IN THE HEMOSTASIS VALVE OR THE TUBE BEFORE USING THE PRODUCT, OR DUE TO THE INFLUENCE OF SUCH AS THE CONNECTION CONDITION OF THE DEVICE CONNECTED TO THE SIDE PORT, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. THE Y-CONNECTOR DOES NOT HAVE THE ABILITY TO ACTIVELY PUMP OR DRAIN LIQUID OR AIR. USER SHOULD ONLY USE THIS DEVICE AFTER AIR HAS BEEN COMPLETELY REMOVED FROM THE LUMEN AND THE FIXED VALVE SHOULD BE IN THE CLOSED POSITION WHEN NEGATIVE PRESSURE IS APPLIED TO THE Y-CONNECTOR TO PREVENT AIR FROM BEING DRAWN INTO THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE YOU AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR WAS DRAWN IN THE PRODUCT. THE Y-CONNECTOR USED AT ANGIOGRAPHY, AIR OBSERVED IN THE Y-CONNECTOR AND AIR FLOWED INTO THE PATIENT. AT TEMPORARY, THE PATIENT'S ST ELEVATED OBSERVED ON THE ELECTROCARDIOGRAM. THEN THE Y-CONNECTOR REPLACED AND OPERATION WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105477 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL GOODMAN CO., LTD. YOK0G YACC23K017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other