BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET - SMARTEC

    MDR report key: 21816436 · Received April 10, 2025

    Report

    Report Number
    21816436
    Event Type
    Death
    Date Received
    April 10, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 3, 2025
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KOC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PERSON INVOLVED WAS A HEMODIALYSIS PATIENT WITH A CENTRAL VENOUS CATHETER IN HER CHEST. ARRIVED FOR REGULARLY SCHEDULED DIALYSIS TREATMENT. BLOOD PRESSURE WAS 115/80, PULSE WAS 73. HEMODIALYSIS TREATMENT WAS INITIATED AT 10:37AM VIA THE CENTRAL VENOUS CATHETER WITH THE HEMACLIP CONNECTOR ATTACHED. AT 11:31 BLOOD PRESSURE WAS 154/71, PULSE 66, BLOOD FLOW RATE WAS 400, DIALYSATE FLOW RATE WAS 800. AT APPROXIMATELY 11:45 PATIENT WAS FOUND UNRESPONSIVE WITH BLOOD NOTED LEAKING FROM THE CONNECTION OF COMBI SET VENOUS BLOOD LINE TO THE PATIENT'S CENTRAL VENOUS CATHETER LIMB. DIALYSIS TREATMENT TERMINATED, 3 LITERS OF NORMAL SALINE WAS ADMINISTERED AND CPR WAS INITIATED, 911 ACTIVATED. PATIENT TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471823 COMBI SET - SMARTEC HEMODIALYSIS BLOOD LINE KOC FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death FRESENIUS 2008T DIALYSIS MACHINE| HEMACLIP CONNECTOR DEVICE