BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS MEDICAL CARE HEMACLIP BLOODLINE CONNECTOR CLI

    MDR report key: 7154196 · Received December 21, 2017

    Report

    Report Number
    7154196
    Event Type
    Death
    Date Received
    December 21, 2017
    Date of Event
    December 6, 2017
    Report Date
    December 13, 2017
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    APPROXIMATELY 2.25 HOURS INTO A SCHEDULED 3 HOUR HEMODIALYSIS TREATMENT, PATIENT WAS FOUND NON-RESPONSIVE. MOST RECENT VS (10 MINUTES PRIOR): B/P 141/54, PULSE 98. THE VENOUS LINE WAS NOTED TO BE DISCONNECTED WITH HEMACLIP STILL IN PLACE. THE VENOUS BLOODLINE AND CVC VENOUS LINE WERE CLAMPED. THE BLOOD PUMP WAS STOPPED. PATIENT WAS PLACED ON LEFT SIDE, OXYGEN APPLIED AND 911 CALLED. AED WAS APPLIED; CPR WAS INITIATED. A TOTAL OF 400 ML NORMAL SALINE WAS INFUSED; TWO SHOCKS ADMINISTERED WITH AED. PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMS WHERE SHE LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920443 FRESENIUS MEDICAL CARE HEMACLIP BLOODLINE CONNECTOR CLI HEMACLIP KOC FRESENIUS MEDICAL CARE NORTH AMERICA 17KR06009

    Patients

    Seq Age Sex Outcome Treatment
    0 75 YR Death