BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 276688 · Received May 5, 2000

    Report

    Report Number
    2937457-2000-00027
    Event Type
    Death
    Date Received
    May 5, 2000
    Date of Event
    April 11, 2000
    Report Date
    April 11, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT A PT COMPLAINED OF FEELING BAD DURING A HEMODIALYSIS TREATMENT. THE NURSE NOTICED THAT THERE WAS A LOT OF FOAM IN THE ARTERIAL LINE, ARTERIAL CHAMBER AND VENOUS LINE BUT DID NOT KNOW IF THERE WAS ANY IN THE VENOUS CHAMBER. THE NURSE STATED THAT THE SOURCE OF AIR MUST HAVE BEEN THE CONNECTION BETWEEN THE ARTERIAL LINE AND THE PT'S CATHETER. THERE WAS NO MACHINE ALARM. THE NURSE STOPPED THE BLOOD PUMP AND CLAMPED THE VENOUS LINE. THE PT COMPLAINED OF SHORTNESS OF BREATH, BECAME HYPOTENSIVE AND CYANOTIC AND CODED WITHIN 5 MINUTES. THE PT WAS TRANSFERRED TO ICU AND EXPIRED WITHIN ONE HOUR. CAUSE OF DEATH IS UNKNOWN. NO AUTOPSY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE-NORTH AMERICA 2008E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death