BEUDAMED
    FDA Adverse Event Death Summary report: N

    LHK, CA, LEFT HEART 360I

    MDR report key: 21495943 · Received February 28, 2025

    Report

    Report Number
    3015910259-2025-00013
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    August 27, 2024
    Report Date
    February 28, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 DURING A LEFT HEART CATHETERIZATION, AN AIR INJECTION WAS RECORDED WITH SUBSEQUENT DEATH OF THE PATIENT. THE CUSTOMER COULD NOT ATTRIBUTE THE AIR INJECTION TO ANY DEFINABLE MALFUNCTION OF THE MANIFOLD SYSTEM. THERE IS NO FURTHER INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 DURING A LEFT HEART CATHETERIZATION, AN AIR INJECTION WAS RECORDED WITH SUBSEQUENT DEATH OF THE PATIENT. THE CUSTOMER COULD NOT ATTRIBUTE THE AIR INJECTION TO ANY DEFINABLE MALFUNCTION OF THE MANIFOLD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528286 LHK, CA, LEFT HEART 360I OEZ MEDLINE INDUSTRIES, LP 0000107115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death