BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180 NR DIALYZER

    MDR report key: 1531312 · Received November 9, 2009

    Report

    Report Number
    1531312
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    October 12, 2009
    Report Date
    November 9, 2009
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY UPON INITIATION OF HEMODIALYSIS, A VISIBLE BLOOD LEAK WAS OBSERVED IN THE DIALYSATE LINES OF THE DIALYSIS MACHINE. THE BLOOD PUMP WAS IMMEDIATELY STOPPED AND BLOOD LINES WERE CLAMPED. PATIENT'S NEEDLE LINES WERE FLUSHED AND PATIENT WAS MOVED TO A NEW MACHINE WITH A NEW DIALYZER SYSTEM. BIOTECH WAS NOTIFIED AND INSTRUCTIONS BY HIM WERE GIVE TO DISPOSE OF THE SYSTEM, AND TO RINSE AND BLEACH MACHINE ACCORDING TO UNIT PRACTICE. THE MACHINE WAS THEN PULLED FROM THE FLOOR FOR FURTHER DISINFECTION. LOT NUMBERS WERE TAKEN FROM THE DIALYZER FOR FUTURE REFERENCE IF NECESSARY. THE PATIENT HAD APPROXIMATELY 200CC BLOOD LOSS. PATIENT'S LAST HEMOGLOBIN WAS 11.6

    Description of Event or Problem · 1

    IMMEDIATELY UPON INITIATION OF HEMODIALYSIS, A VISIBLE BLOOD LEAK WAS OBSERVED IN THE DIALYSATE LINES OF THE DIALYSIS MACHINE. THE BLOOD PUMP WAS IMMEDIATELY STOPPED AND BLOOD LINES WERE CLAMPED. PATIENT'S NEEDLE LINES WERE FLUSHED AND PATIENT WAS MOVED TO A NEW MACHINE WITH A NEW DIALYZER SYSTEM. BIOTECH WAS NOTIFIED AND INSTRUCTIONS BY HIM WERE GIVE TO DISPOSE OF THE SYSTEM, AND TO RINSE AND BLEACH MACHINE ACCORDING TO UNIT PRACTICE. THE MACHINE WAS THEN PULLED FROM THE FLOOR FOR FURTHER DISINFECTION. LOT NUMBERS WERE TAKEN FROM THE DIALYZER FOR FUTURE REFERENCE IF NECESSARY. THE PATIENT HAD APPROXIMATELY 200CC BLOOD LOSS. PATIENT'S LAST HEMOGLOBIN WAS 11.6

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180 NR DIALYZER DIALYZER KDI FRESENIUS MEDICAL CARE NORTH AMERICA N/A 09KU02004

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR DIALYSIS| DIALYSIS