BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OKAY II

    MDR report key: 18984265 · Received March 26, 2024

    Report

    Report Number
    3007835716-2024-00011
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    December 6, 2023
    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 IN THE PRODUCT'S FUNCTIONALITY, SO THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS OF THE PRODUCT. IT IS CONSIDERED THAT THE REPORTED EVENT WAS CAUSED BY AIR GETTING INTO THE PRODUCT DURING OPERATION OF THE CONCOMITANT DEVICE DUE TO THE INSERTION SPEED OF THE DEVICE INSERTED INTO THE PRODUCT OR THE INFLUENCE OF THE EQUIPMENT CONNECTED TO THE SIDE PORT, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    AIR WAS DRAWN IN WHEN CONCOMITANT DEVICE WAS INSERTED INTO THE PRODUCT. AIR ENTERED THE PATIENT'S BODY, TEMPORARILY DISRUPTING THE ELECTROCARDIOGRAM, SO MEDICATION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060779 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL GOODMAN CO., LTD. YOK0A YACC23H002

    Patients

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