BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OKAY II

    MDR report key: 19009513 · Received March 31, 2024

    Report

    Report Number
    3007835716-2024-00104
    Event Type
    Injury
    Date Received
    March 31, 2024
    Date of Event
    July 27, 2021
    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. THE INVESTIGATION FOUND NO ABNORMALITIES WITH THE PRODUCT. NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS OF THE PRODUCT. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY AIR GETTING DUE TO THE CONTRAST BEING PERFORMED WITH THE FIXED VALVE OF THE PRODUCT NOT CLOSED, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    AIR ENTERED THE CORONARY ARTERY DURING THE CONTRAST IMAGING. SINCE THE PATIENT'S BLOOD PRESSURE TEMPORARILY DECREASED, MEDICATION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594982 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL GOODMAN CO., LTD. YSS0B YA2011132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention