BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNETIXS VASCULAR

    MDR report key: 16098580 · Received January 4, 2023

    Report

    Report Number
    0001222117-2023-60002
    Event Type
    Death
    Date Received
    January 4, 2023
    Date of Event
    October 23, 2022
    Report Date
    December 28, 2022
    Manufacturer
    UNETIXS VASCULAR INC
    Product Code
    JAF
    PMA / PMN Number
    K904392/B
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON NOVEMBER 28TH UNETIXS VASCULAR BECAME AWARE OF AN INCIDENT IN WHICH A HOSPITAL TECHNICIAN AND AN AGENCY TECHNICIAN TRAINEE CONNECTED THE AIR INFLATION LINE FROM A MULTILAB 2000 SERIES 2 LHS ERGO TO THE RIGHT SALINE LOCK OF A PATIENT IV, CAUSING AN AIR EMBOLISM AND DEATH. THE HOSPITAL SUBITTED A PAPER COPY OF MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472260 UNETIXS VASCULAR VASCULAR DIAGNOSTIC EQUIPMENT JAF UNETIXS VASCULAR INC 11949-0000-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death