BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS HEMACLIP BLOODLINE CONNECTOR DEVICE

    MDR report key: 1444751 · Received March 26, 2009

    Report

    Report Number
    1444751
    Event Type
    Death
    Date Received
    March 26, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 25, 2009
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 6:15 PM, PT WAS FOUND UNRESPONSIVE AND UNCONSCIOUS. RN RESPONDED TO PCT REQUEST, WHO WAS ATTENDING TO THE DIALYSIS MACHINE ALARM BY ATTEMPTING TO RESET THE BLOOD PUMP AND WAS UNABLE TO RE-ENGAGE THE PUMP. UPON ARRIVAL AT THE PT STATION, RN OBSERVED A LARGE AMOUNT OF BLOOD ON FLOOR, CHAIR AND PT'S CLOTHING. RN ALSO OBSERVED SEPARATION OF THE VENOUS BLOOD LINE FROM THE CATHETER LUMEN AND THE HEMOSAFE DEVICE WAS NOT IN PLACE ON THE VENOUS LINE. PT PLACED IN TRENDELENBURG POSITION, SALINE ADMINISTERED. PT WAS TRANSFERRED TO THE HOSPITAL VIA AMBULANCE. APPROXIMATE AGE OF DEVICE: 3 YEARS FOR THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HEMACLIP BLOODLINE CONNECTOR DEVICE BLOODLINE CONNECTOR CLIP KOC FRESENIUS MEDICAL CARE NORTH AMERICA 8NR 308
    2 COMBI SET TRUE FLOW SERIES HEMODIALYSIS BLOOD TUBING SET FJK FRESENIUS MEDICAL CARE NORTH AMERICA
    3 FRESENIUS 2006 K HEMODIALYSIS MACHINE KDI FRESENIUS USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| O| S 4:08 PM| ZEMPLAR 5 MCG IVP| 5:45 PM