BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    MDR report key: 20189515 · Received September 9, 2024

    Report

    Report Number
    MW5159437
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ASSET MEDIKAL TASARIM SAN. TIC. A.S.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S BLOOD LINE BECAME DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT WAS RECEIVING A DIALYSIS TREATMENT, WHICH RESULTED IN BLOOD LOSS. THE PATIENT'S HEMOGLOBIN WAS 9.9 ON (B)(6) 2024 PRIOR TO THE EVENT, AND THE PATIENT WAS ON MIRCERA 50 MCG EVERY 4 WEEKS. ON (B)(6) 2024 THE DAY AFTER THE DISCONNECTION, THE PATIENT'S HEMOGLOBIN DROPPED TO 7.8. THIS REQUIRED THE MIRCERA DOSE TO BE INCREASED TO 100 MCG EVERY 2 WEEKS. THIS WAS ORIGINALLY REPORTED ON 8/6/2024, HOWEVER, SPECIFIC INFORMATION FOR THIS PATIENT WAS NOT PROVIDED. THIS IS THE ONLY ONE OF THE 6 THAT WAS PROVIDED WHO SUSTAINED HARM. HOWEVER, THE POTENTIAL FOR SERIOUS INJURY OR EVEN DEATH FROM EXSANGUINATION IS GREAT IF THERE IS A DISCONNECTION DURING THE DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574584 FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA ASSET MEDIKAL TASARIM SAN. TIC. A.S. (01)08699443580044

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| O