BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 230660 · Received June 30, 1999

    Report

    Report Number
    2937457-1999-00041
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    June 1, 1999
    Report Date
    June 1, 1999
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FACILITY REPORTED VIA MEDWATCH THAT THERE WAS MINIMAL BLOOD LOSS (<50 ML) THROUGH A CUT ON THE BLOOD PUMP SEGMENT TUBING DURING A HEMODIALYSIS TREATMENT ON 05/28/1999. THE SAME MACHINE WAS USED ON 06/01/1999 AND BLOOD WAS NOTED TO BE LEAKING FROM THE BLOOD PUMP SEGMENT. BLOOD IN THE ARTERIAL LINE WAS REINFUSED AND THE REST OF THE EXTRACORPOREAL CIRCUIT WAS DISCARDED. ESTIMATED BLOOD LOSS THROUGH THE LEAKING SEGMENT AND WHAT WAS DISCARDED WAS ABOUT 500 ML. NO MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO PATIEN COMPLICATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other